January 6, 2016 6:47pm

Caladrius Bioscience (CLBS) dropped -38.68% or -$0.48 to $0.65 in the aftermarket …

 

Do you know why, subscribe for access or take your losses without complaining …


 

I say what others won't, so you can do what others can't!

 

Haven’t been wrong - expect the week to fluctuate between less gains and more losses or maybe the reverse if geo-politico issues continue to inflame the markets!!

 

 

U.S. stocks held lower in choppy trade Wednesday, pressured by continued concerns about global economic growth, low oil prices and increased geopolitical tensions.

The NASDAQ closed DOWN -55.67 or -1.14% to 4,835.77 and the DOW closed DOWN -257.97 or -1.50% to 16,900.69.

 

 

Shaken not stirred:

 

Caladrius Biosciences (NASDAQ:CLBS), formerly NeoStem (NBS), is down 38.68% after hours (was down -$0.01 at the close with 294 K share  volume <3 month average = 294K shares>) in response to its announcement that it will terminate the P3 development of its lead product candidate - CLBS20, for the treatment of metastatic melanoma due to improved outcomes of combination therapies and immune checkpoint inhibitors.

  • CLBS does not believe CLBS20 as monotherapy can sufficiently distance itself from alternative treatments in melanoma so it will shift its priorities to collaborating with another firm to advance development in a combination approach.

The decision will result in the elimination of 40 jobs at its Irvine, CA facility. A restructuring charge of $1 M will be recorded this quarter.

  • CLBS will focus its development efforts on its T regulatory cell therapy candidate, CLBS03. A P2 clinical trial in adolescents with recent-onset type 1 diabetes should commence this quarter – a VERY crowded and competitive disease state!

Management “expects” $23 M in total revenues for 2015 and more than $30 M this year. To accommodate the projected growth, it expects to spend $6 M in capital improvements at its Allendale, NJ site.

 

Another question – WHY will it need the new CEO’s <Mazzo> Taj Mahal office building in Basking Ridge, NJ – still a stupid move! It is his time to GO without an exorbitant $$ exit handshake!

  • The cardiac program was declared DOA. PCT hasn’t been very profitable and is still dependent on the CLBS for funding. The issue - crowded and competitive “spaces”! 

 

CLBS will host a conference call tomorrow morning at 8:30 am ET to discuss current and future plans.

 

 

Henry’omics:

From the title: eviscerated – my, version is deprived of any acceptable and/or vital force!

  • The stem, cell and gene therapy RegMed (SCGT&RM) sector opened negative, stayed negative to the mid-day and closed negative (of 43 covered companies);

Until we get some stabilization in oil we're going to have some problems in the SCGT&RM sector!

 

 

My fear gauge or the CBOE Volatility Index (VIX), widely considered the best gauge of fear in the market traded

·         Wednesday traded down near 20.5 following

·         Tuesday traded near 19.5 <down from 20.5> following

·         Monday traded near 22 after earlier topping 23 to hit its highest level in two weeks following

·         Thursday traded near 18 following

·         Last Wednesday‘s trading near 17.

 

 

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

  • The stem, cell and gene therapy RegMed sector opened negative with an A/DL of 5/36 and 2 flats versus Tuesday’s negative 5/17 and 6 flats as compared to Monday’s negative A/DL of 7/32 and 4 flats;
  • Wednesday’s negative mid-day with an A/DL of 5/36 and 2 flats compared to Tuesday’s negative A/DL of 17/20 and 6 flats as compared to Monday’s negative 5/38 and 0 flats;
  • Wednesday closed negative with an A/DL of 5/36 and 2 flats following Tuesday’s close with a negative A/DL of 19/22 and 2 flats as compared to Monday’s negative A/DL of 7/33 and 3 flats.

 

 

Wednesday’s indication round-up:  2 hits and 5 miss – at least I articulate the score:

  • Applied Genetic Technologies (AGTC) closed DOWN- miss;
  • bluebird bio (BLUE) closed DOWN – miss;
  • Capricor (CAPR) closed DOWN – hit;
  • Fate Therapeutics (FATE) closed DOWN – miss;
  • Harvard Apparatus RT (HART) closed DOWN – hit;
  • Juno Therapeutics (JUNO) closed DOWN – miss;
  • Verastem (VSTM) closed DOWN – miss;

 

 

Riding the indexes and ETFs roller-coaster:

The iShares Biotechnology Stocks ETF (IBB) closed DOWN on Wednesday -5.84 or -1.79% following

·         Tuesday’s +0.09 or +0.03% after

·         Monday’s -11.46 or -3.39% following

·         Thursday’s decline of -2.53 or -0.74% after

·         Last Wednesday’s  -2.25 or -0.66%;

The NASDAQ Biotechnology index (NBI) closed DOWN on Wednesday -61.10 or -1.79% following

·         Tuesday’s -6.50 or -0.19% after

·         Monday’s -112.78 or -3.19% following

·         Thursday’s decline of -25.49 or -0.71 after

·         Last Wednesday’s decline of -24.16 or -0.67%;

The Russell 2000 (IWM) closed DOWN on Wednesday -1.68 or -1.52% following

·         Tuesday’s +0.09 or +0.03% after

·         Monday’s -2.61 or -2.32% following

·         Thursday’s decline of -1.42 or -1.25% after

·         last Wednesday’s  -1.16 or -1.01%;

The SPDR SD&P Biotech ETF (XBI) closed DOWN on Wednesday -2.87 or -4.27% following

·         Tuesday’s -0.61 or -0.90% after

·         Monday’s -2.41 or -3.43% following

·         Thursday’s decline of - 0.66 or -0.93% after

·         last Wednesday’s decline of -0.79 or -1.10% …

 

 

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

  • Open: NEGATIVE with 36 decliners, 5 advancers and 2 flats;
  • Mid-day (12:30 pm): NEGATIVE with 36 decliners, 5 advancers and 2 flats;
  • Closing bell:  NEGATIVE with 36 decliners, 5 advancers and 2 flats

 

 

Who was UP – the only 5:

  • Histogenics (HSGX) closed up +$0.17 to $3.38;
  • VistaGen (VSTA) +$0.05 to $9.50;
  • MiMedx (MDXG) +$0.04 to $8.90;
  • Neuralstem (CUR) +$0.04 to $1.08;
  • AxoGen (AXGN) +$0.01 to $5.01

 

 

Who closed down – top 5:

  • Kite Pharma (KITE) closed down -$5.18 to $57.13;
  • Bluebird bio (BLUE) -$3.53 to $58.23;
  • Spark Therapeutics (ONCE) -$3.26 to $37.18;
  • Juno Therapeutics (JUNO) -$3.17 to $39.25;
  • Intrexon (XON) closed down -$2.40 to $26.19;

 

 

Flat:

  • Ocata Therapeutics (OCAT) at $8.41;
  • ReNeuron (RENE.L) at $3.25;

 

 

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.