April 26, 2021 7:54am

Beware the Ides of Q1 Earnings season beginning

Earnings this week: Brainstorm Cell Therapeutics (BCLI) on Monday, 4/26, MiMedx (MDXG) on Wednesday 4/28, Alnylam Pharmaceuticals (ALNY) on Thursday, 4/29

News: uniQure N.V. (QURE the U.S. FDA has removed the clinical hold on the Company’s hemophilia B gene therapy program after determining they satisfactorily addressed all issues identified by the FDA related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial.

Pre-open indications:  3 BUYs, 11 SELLs and 1 Maintain SELL

Mentions: CLLS, FIXX, QURE, AGTC, KDNY, ADVM, CRSP, EDIT, MDXG, MESO, PSTI, VCEL, PGEN, VYGR, BSTG

My version of the morning’s “numbers” is written to be informative rather than just about changes to share pricing; it’s what happened or will materialize after the opening and what might happen during the session

My comments are important in trying to distinguish the temporary from real pricing progress.

Dow futures are UP +0.09% (+29 points), S&P futures are DOWN -0.10% (-4 points) and NASDAQ futures are DOWN -0.35% (-49 points)

 

Futures are drifting, mixed on Monday and flat; Dow futures are barely up while the S&P futures are down, the Nasdaq futures are dropping like a stone

European markets were soft

Asia-Pacific markets were mixed as investors continued to monitor the Covid situation in India.

  • The Covid situation in India remains severe as the country continues to battle a startling rise in new coronavirus infections. On Monday, more than 350,000 new daily infections were registered.
  • The Biden administration has said it will immediately make raw materials needed for India’s coronavirus vaccine production available. The U.S. response comes after Britain, France and Germany also pledged aid to India over the weekend. <CNBC>

 

Data Docket: as the title suggested, a busy week ahead between a Fed meeting, the debut of President Biden’s “American Families Plan,” more inflation data and ongoing corporate earnings reports. The U.S. Federal Reserve is holding a monetary policy meeting on Tuesday and Wednesday, and market participants will be closely watching for clues on whether the central bank is nervous about the prospect of rising inflation.

 

Henry’omics:

Last week, the S&P dipped less than -0.1% as the Dow fell -0.5% and the Nasdaq dived -0.3%.

 

Friday’s evening’s recap: “an answer to this a.m.’s question, “what will be sustainable”? Many were slotted to the downside while more plus one (1) split to the upside” …

  • The Nasdaq closed UP +198.40 points (+1.44%);
  • The IBB closed up to +0.42% and XBI closed down -0.18%;
  • Sector volume was LOW with 1 of the 16-upside having higher than the 3-month average volume with the volume of 0 of 17-downside having higher than the 3-month average volume;
  • The CBOE Volatility Index (VVIX: INDEX) was down -1.38 points or -7.38% at 17.33;
  • Friday’s percentage (%) of the 16-upside were +0.52% (CRSP) to +5.36% (MDXG) while the 17-downside ranges from -0.45% (BLUE) to -4.76% (BSTG);

Q2/21 and April: 8 negative and 8 positive closes

Q1/21:

  • March: 10 positive, 12 negative and 1 neutral closes
  • February: 9 positive, 10 negative closes and 1 holiday
  • January: 10 positive, 9 negative closes and 1 holiday

 

Companies in my headlights – It’s your decision; I provide an idea and context:

Biostage (BSTG): Questions continue … Maintaining Sell

Biostage (BSTG) closed down -$-0.05 to $1.10 with 151 shares traded after Thursday’s +$0.15 to $1.15 with 1,202 shares traded, Wednesday’s flat at $1.00 with 250 shares traded, Tuesday’s -$0.28 to $1.00 with 6,816 shares traded and last Monday’s -$0.06 (was down -$0.23 until minutes before the close) to $1.28 with 1,760 shares traded.

Question#1: From a March 19, 2020 filing, “the FDA notified the Company that the clinical hold on its CEI product candidate has been removed as noticed in a March 19, 2020 filing with the ability to proceed with its First in Human (FIH) Clinical study. WHY has there been no further actions after a year and a month’s time?

Question#2: WHY do they NOT update their website as more of their leadership walks away? WHY do they NEED to misrepresent their management team?

Question#3: WHERE is the next level of funding coming from, is it further warrant execution - the only source of cash generation for further funding? Will the $1 million dollars remaining in the “till” last through the quarter? Should its “runway” be considered extremely short or even non-existent?

MINORITY PUBLIC shareholders are waiting, watching and weighing responses to MAINTAIN their RIGHTS.

 

The morning’s indications (from Friday’s close and today's pre-market), what I “discern” are in store:

BUYS:

  • Cellectis SA (CLLS) closed down -$0.16 with a positive +$0.51 or +2.67% pre-market indication;
  • Homology Medicine (FIXX) closed up +$0.06 with a positive +0.20 or +2.95% pre-market indication;
  • uniQure NV (QURE) closed down -0.68 with a positive +$4.52 or +14% pre-market indication on news (see title section>

Sell into Strength:

  • Applied Genetic Technologies (AGTC) closed up +$0.14 with a positive +$0.04 or +0.94% aftermarket indication;
  • Chinook Therapeutics (KDNY) closed down -$0.36 with a positive +$0.15 or +1.02% aftermarket indication;
  • Adverum Biotechnologies (ADVM) closed down -$0.06 with a positive +$0.29 or +1.49% aftermarket indication;
  • CRISPR Indication (CRSP) closed up +$0.66 with a positive +$1.40 or +1.11% pre-market indication;
  • Editas Medicine (EDIT) closed up +$0.62 with a positive +$0.14 or +0.38% aftermarket indication;
  • MiMedx MDXG) closed up +$0.57 with a positive +$0.49 or +4.37% aftermarket indication;
  • Mesoblast (MESO) closed down -$0.23 with a positive +$0.12 or +1.45% aftermarket indication;
  • Pluristem (PSTI) closed down -$0.03 with a positive -$0.02 or -0.46% pre-market indication;

SELL:

  • Vericel (VCEL) closed up +$1.96 with a negative -$2.59 or -4.35% aftermarket indicator;
  • Precigen (PGEN) closed down -$0.14 with a negative -$0.12 or -1.49% aftermarket indication;
  • Voyager therapeutics (VYGR) closed down -$0.03 with a negative -$0.12 or -2.57% aftermarket indication;

 

The BOTTOM LINE: The key to the week will be the reception that the first two (2) companies to announce earnings take shape.

The sentiment factor is not on the side of the cell and gene therapy sector which suffers the absence of a catalysts.

The only “thing” we’ve got to look forward to is the next wave of Q1 earnings or as I call them LPS (loss-per-share) numbers.

I’m STILL a “beware or the cautious man” whose focus has always been “warning analysis” … my advice, trim and skim any new highs if one can!” I also see some lows that could be in the “pick-up” stock game.

I say, re-asses your risk as some questionable earnings are on the horizon.

Welcome to my world of defining the “grey’ in our universe!

 

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.