November 15, 2018 5:37pm

IBB rallies +2.19% as uniQure NV (QURE) rocks +$8.13 or +35.66% reporting that all three patients enrolled in the study achieved and sustained therapeutic levels of Factor IX (FIX) activity at six weeks after a single administration of AMT-061

Quarterly financial results: Mesoblast (MESO +$0.17 before reporting)

 

Who is defining the metrics for investors?

 

Some have stated, “I am the “weatherman” of the sector; forecasting and presenting conditions of the sector in a given period.”

 

During “earning’s” season, traders vote by buying and selling shares, and in the short run, the trades happen at the levels dictated by whether the buyers or sellers are motivated by meeting “street” expectation  versus LPS (loss-per-share) as compared to net income.

 

Daily analytics and metrics:

  • The Dow closed up +208.77 points or +0.83% to 25,289.27
  • The S&P closed up +28.62 points or +1.06% to 2,730.20
  • The NASDAQ closed up +122.64 points or +1.72% to 7,259.03

 

From the pre-open newsletter, “correction needed; the more the oversold become, the quicker the trading response however, its trashing future investment – i.e. trust of investors, funds and even traders. Equities are reduced to “short” trading vehicles not, near or long-termed investment candidates.”

 

The advance/decline line scenario of 45 covered companies:   

  • The open was positive with an A/DL of 32/12 and 1 flat;
  • The mid-day was positive with an A/DL of 33/12 and 0 flats;
  • The close was positive with an A/DL of 33/12 and 2 flats;

 

Pre-open indications:

 As I had stated, after a precipitous drops in value since the previous Thursday – set a stage for an UPSIDE bounce

 

Quarterly financial results: Mesoblast (MESO)

The net loss was $19.5 M, or -$4.07 per share, for Q1/19, compared with $7 M, or -$1.58 per share in Q1/18.

Significant increase in revenues to $11.6 M in Q1/19, compared with $1.2 M in Q1/18

Pro-forma cash on September 30, 2018 was $95.1 million including:

  • $55.1 M balance sheet cash, and
  • $40 M from Tasly Pharmaceutical Group (Tasly) received in October 2018 in relation to the strategic cardiovascular partnership in China announced in July 2018
  • An additional $50 M may be available under existing arrangements with Hercules Capital and NovaQuest, subject to achievement of certain milestones.

 

Five (5) key metrics: 

… Greatest volume to the downside:  MDXG, ADRO, ONCE, FATE and ONVO

… Upside volume was weighted to:  QURE, HSGX, SGMO, VSTM and XON

… Weakness ($) to the downside:  CLLS (-$1.89), ONCE (-$1.81), RENE.L (-$1.00), BLFS (-$0.19) and FATE (-$0.13)

… Best moves ($) to the upside:  QURE (+$8.130, BLUE (+$6.29), ALNY (+$4.30), SAGE (+$3.83) and RGNX (+$3.37)

… The iShares NASDAQ Biotechnology (IBB) closed:

  • Thursday was up +2.19% after NOT indicating in the pre-market;
  • Wednesday was down -2.03% after NOT indicating in the pre-market;
  • Tuesday was down -0.4% after indicating a POSITIVE +0.06% in the pre-market;
  • Monday was down -3% after indicating a POSITIVE +0.06% in the pre-market;
  • Friday was down -2.21% after indicating a POSITIVE +0.08% in the pre-market;
  • Thursday was down -0.77% after NOT indicating in the pre-market;
  • Last Wednesday was up +2.3% after NOT indicating in the pre-market;

 

Henry’omics:

The major stock indexes snapped multiday losing streaks on Thursday as uniQure NV (QURE) lead the herd higher and bluebird bio (BLUE) rebounded after dipping earlier in the week.

  • QURE reported that all three patients enrolled in the study achieved and sustained therapeutic levels of Factor IX (FIX) activity at six weeks after a single administration of AMT-061
  • The initial safety results from the study also were encouraging. No patient experienced a material decline in FIX activity following the administration of AMT-061. No patients reported any bleeding. None required infusions of FIX replacement therapy.
  • No serious adverse events were reported in the study, either. The only issue identified came from one patient who experienced a mild increase in liver enzyme levels.
  • However, the issue was quickly resolved and didn't require any other treatment <MotleyFool>.
  • Patients with hemophilia B today typically require periodic Factor IX infusion therapy. If uniQure ultimately wins approval for AMT-061, the company could have a significant market opportunity, as AMT-061 is only administered once. 
  • Although the P2 results announced today were only for three patients, there appears to be considerable promise for AMT-061.
  • If QURE's P3 results are equally successful, the stock should have even more room to run.

 

Sentiment across the globe has improved on reports that China has delivered a written response to U.S. trade demands.

The hard part for most investors is not so much that quarterly results are mostly disappointing... the real issue is what clinical results could be announced by year’s end and by the first half of 2019.

 

Crispers bounced back up after Wednesday’s hard close after Tuesday’s ups:

  • CRSP closed up (Thursday) +$1.63 after Wednesday’s -$1.72 after Tuesday’s+$0.31, EDIT closed up (Thursday) +$1.18 post Wednesday’s -$2.08 after Tuesday’s +$0.79 and
  • NTLA closed up (Thursday) +$0.31 after Wednesday’s -$1.25 after Tuesday’s +$0.96;

I kept telling many, they had become trading vehicles and they have been!

 

Applied Genetic Technologies (AGTC) closed up +$0.07 after Wednesday’s -$0.32 to $6.83 after Tuesday’s +$0.10, Monday’s +$0.35 or +5.22% to $7.05, Friday’s $6.70 and last Thursday’s $7.01;

 

Tonight’s percentage (%) indicators:

  • Review the range of the 33 upside from +0.50% (FIXX) to +35.66% (QURE) while the 12 downside ranged from -0.41% (MDXG) to -7.75% (CLLS) with 0 flat closes.

Volume stat:

  • 15 out of 35 of the upside had higher (than the 3 month average) volume
  • 6 out of the 12 downside experienced greater volume (than the 3 month average).

 

November sessions:

Thursday closed POSITIVE with 12 decliners, 33 advancers and 0 flat;

Wednesday closed NEGATIVE with 36 decliners, 7 advancers and 2 flats;

Tuesday closed NEUTRAL with 21 decliners, 21 advancers and 3 flats;

Monday closed NEGATIVE with 40 decliners, 4 advancers and 1 flat;

Friday closed NEGATIVE with 39 decliners, 6 advancers and 0 flat;

Thursday closed NEGATIVE with 26 decliners, 19 advancers and 1 flat;

Wednesday closed POSITIVE with 12 decliners, 32 advancers and 1 flat;

Tuesday closed NEGATIVE with 22 decliners, 21 advancers and 2 flats;

Monday closed NEGATIVE with 35 decliners, 7 advancers and 3 flats;

Friday closed POSITIVE with 20 decliners, 22 advancers and 3 flats;

Thursday (11/1) closed POSITIVE with 3 decliners, 42 advancers and 0 flat;

  • In 23 sessions in October – there were 17 negative closes and 6 positive closes
  • In 19 sessions in September – there were 10 negative closes and 9 positive close;
  • In 21 August sessions – 6 had negative and 15 had positive closes

 

 

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.