September 8, 2021 5:20pm

Sector news: Global Blood Therapeutics (GBT +$0.21) announced that the FDA has accepted the supplemental new drug application (sNDA) as well as a new drug application (NDA) for its only marketed drug, Oxbryta (voxelotor). The sNDA is seeking approval of Oxbryta for the treatment of sickle cell disease (SCD) in children aged four to 11 years, while the NDA is seeking approval for a new age-appropriate dispersible tablet dosage form of Oxbryta (300 mg) in pediatric patients.

Pre-open indications: 2 HITs and 4 MISS

My comments try to distinguish the temporary from real pricing digression or progress with a 360-degree view.

Some investors might love stem, cell and gene therapy stocks for their lottery ticket-like returns when a company strikes medical gold. A lottery ticket, however, costs only a buck or two, while getting a biotech company wrong can hurt a lot more than that.


The Dow closed DOWN -68.93 points (-0.20%); the S&P closed DOWN -5.96 points (-0.13%) while the Nasdaq closed DOWN -87.69 points (-0.57%)

 

Henry’omics:

The Dow, S&P and Nasdaq fell on Wednesday. Investors have been bracing for volatility in September, one of the seasonally weakest months of the year.

 

Data Docket: The Labor Department released the Job Openings and Labor Turnover Survey, which showed job openings rose to a record 10.9 million in July. Job openings outnumbered the unemployed by more than 2 million in July as companies struggled to fill a record number of vacancies.

 

RegMed/Stem/Cell and Gene therapy’s 35 covered equities’ Advance/Decline (A/D) lines:

  • Wednesday opened negative at 9/24, 1 flat and 1 acquired, stayed negative at the mid-day to 10/24 and 1 acquired, closing negative 7/27 and 1 acquired;

 

RegMed Investors’ (RMi) pre-open: “more volatility and some bounces” … https://www.regmedinvestors.com/articles/12084

 

The Biostage (BSTG) Chronicles: “Facts from filed 10-Q” … still a few to report … https://www.regmedinvestors.com/articles/12055

 

Q2/21 Earnings releases … https://www.regmedinvestors.com/articles/11542  … to date:

  • Net Income: 3 and Net losses: 23

 

Key Metrics:

  • Sector volume was LOW with 1 of the 7-upside having higher than the 3-month average volume with very LOW volume of 3 of 27-downside having higher than the 3-month average volume;
  • Wednesday’s percentage (%) of the 7-upside were +0.06% (AXGN) to +20.73% (BSTG) while the 27-downside -0.33% (PSTI) to -4.98% (FATE)

 

The Biostage (BSTG) Chronicles: Wednesday traded +$0.57 with 7,833 shares traded after Tuesday closed down -$0.75 to $2.75 with 6,705 shares traded following Monday’s holiday

Last Friday closed up +$0.39 to $3.50 with 980 shares traded, Thursday closed up +$0.11 with 14,939 shares traded after Wednesday traded 22,299 shares (-$0.36 to $3.00) after Tuesday traded 11,564 shares traded (-$0.44 to $3.36), Monday’s 25,607 shares traded (+$0.75 to $3.80),

The previous Friday traded 13,942 (+$0.47 to $3.07), Thursday traded 3,137 shares, last Wednesday traded 18,472 shares traded (+$0.16 to $2.21), the previous Tuesday closed up +$0.28 with 10,590 shares trade and following last Monday’s +$0.68 with 38,354 shares traded

Following the previous Friday’s -$0.07 with 570 shares traded.

Questions to consider:

  • Another non-healthcare “type” was added to the board of directors; will he “reign” from Foshan, China?
  • Today is just another fact, how the share trades with the “push/promote” - another typical example,
  • WHAT is BSTG’s value proposition, after all the share price pumping?
  • What’s the end game of the “pumping” buys of stock in a company with NO clinical trial after an approved IND for 1.5 years and only three (3) or was it four (4) employees left in a 17,00 sq. foot lab?
  • Have investors considered that the float is MINIMAL compared to the ever-OUTSTANDING shares?
  • WHERE is the SEC?
  • Does the SEC [Securities and Exchange Commission] have a term for this – could it be called an “affinity fraud”?
  • Affinity scams often involve “Ponzi” or pyramid schemes where new investor money is used to pay earlier investors, making it appear as if the investment is successful and legitimate.

 

Pre-open Indications: 2 HITs <SELL:  BioLife Solutions (BLFS -$0.36), ReNeuron (RENE.L -$1.50)> 4 MISS <BUY: Intellia Therapeutics (NTLA -$3.36), CRISPR Therapeutics (CRSP -$1.25), Editas Medicine (EDIT -$2.41), Biostage (BSTG +$0.57)>  

 

There are clear winners and losers

Jumping with share pricing momentum:

  • Biostage (BSTG), bluebird bio (BLUE), Ultragenyx (RARE), Global Blood therapeutics (GBT), MiMedx (MDXG), Chinook Therapeutics (KDNY) - again, AxoGen (AXGN) – again, to name 7 of the 7 inclining of the 35 covered

Hammered in today’s market:

  • Fate Therapeutics (FATE), Intellia Therapeutics (NTLA), Editas Medicine (EDIT), Alnylam Pharmaceuticals (ALNY) - again to name 5 of the 27 declining of the 35 covered

 

Wednesday’s (7 of 7) incliners:

 

  • Biostage (BSTG +$0.57 after Tuesday’s -$0.75);
  • bluebird bio (BLUE +$0.50 after Tuesday’s -$0.63);
  • Ultragenyx (RARE +$0.32 after Tuesday’s -$0.42);
  • Global Blood therapeutics (GBT +$0.21);
  • MiMedx (MDXG +$0.15 after Tuesday’s +$0.12);
  • Chinook Therapeutics (KDNY +$0.03 after Tuesday’s +$0.52);
  • AxoGen (AXGN +$0.01 after Tuesday’s +$0.27);

Wednesday’s (10 of 27) decliners:

 

  • Fate Therapeutics (FATE -$3.64 after Tuesday’s +$0.18);
  • Intellia Therapeutics (NTLA -$3.36 after Tuesday’s -$13.53);
  • Editas Medicine (EDIT -$2.41 after Tuesday’s -$1.52);
  • Alnylam Pharmaceuticals (ALNY -$1.96 after Tuesday’s -$9.19);
  • Vericel (VCEL -$1.57);
  • ReNeuron (RENE.L -$1.50)
  • CRISPR Therapeutics (CRSP -$1.25 after Tuesday’s -$1.45);
  • Regenxbio (RGNX -$0.86 after Tuesday’s -$0.64);
  • Cellectis SA (CLLS -$0.67);
  • Ionis Pharmaceuticals (IONS -$0.58 after Tuesday’s -$1.97);

Closing –1 - Stemline Therapeutics (STML) – acquired

 

Stats:

The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:

  • Wednesday, the IBB closed down -0.96% and XBI closed down -1.16%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Wednesday was down -0.18 points or -0.99% at 17.96

Upside volume:

  • Wednesday: 1 out of the 7-upside had higher than the 3-month average volume;

Downside volume:

  • Wednesday: 3 out of the 27-downside had higher than the 3-month average volume;

Percentage (%) movement/range statistics: price versus percentage …

  • Wednesday’s percentage (%) of the 7-upside were +0.06% (AXGN) to +20.73% (BSTG) while the 27-downside -0.33% (PSTI) to -4.98% (FATE);

 

September, the third month of Q3/21:

Wednesday closed negative with 7 advancers, 27 decliners and 1 acquired

 

The BOTTOM LINE: The month of September begins with the cell and gene therapy sector up for two (2) sessions and down for three (3) sessions and a holiday.

I am still waiting for clinical data and foresee a bumpy September-October.

When you’re on a roller coaster, the only thing you can be sure of is you’ll end up back where you started.

Q2 reporting season has essentially run its course; although a few remain with my questions of WHY so late …?

I’m STILL a “beware or the cautious man” whose focus has always been “warning analysis” … earnings’ season is NOT over … my advice, trim and skim any new highs if one can!”

WHY do I keep analyzing Biostage (BSTG): When one sees an inextricable wrong and morally repulsive scenario; it takes courage, resolve and patience to stay the course of asking the questions without response!

 

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.

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.