September 12, 2023 4:33pm

The Slinky is a stack of coiled metal that oscillates, as it flips head-over-heels to move

Pre-open Indications: 4 Hits and 0 Miss <I’m into profit before a decline>

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The Dow closed DOWN -17.73 points or -0.05%, the S&P closed DOWN -25.56 points or -0.57% while the Nasdaq closed DOWN -144.28 points or -1.04%



We need to more than consider the economic environment - rising rates and inflation to comprehend the micro re “our” universe of cell and gene therapy companies …

Indexes dives heading for its 1st losing day in three (3).

The Nasdaq was pulled lower by sagging technology shares as oil prices jumped on Tuesday while investors looked ahead to key inflation data in anticipation of further clues regarding the way forward for the U.S. Federal Reserve's restrictive monetary policy. <Reuters>


Tuesday (9/12) … RegMed Investors’ (RMi) Opening Bell: “show me the money. To validate indications that equities are valuable or worth having previously bought in; during a volatile market environment, timed upside exits are the right signal to play as multiple up sessions are now suspect in individual sector holdings.”


Pre-Open indications: 4 Hits < BioLife Solutions (BLFS +$0.24), CRISPR Therapeutics (CRSP -$0.70), Editas Medicine (EDIT -$0.17), Vericel (VCEL +$2.46)> and 0 Miss


RegMed/Stem/Cell and Gene Therapy’s 35 covered equities’ Advance/Decline (A/D) lines: what happened – differences …

  • Tuesday’s advance/decline line opened positive at 23 up/ 11 down and 1 flat, stayed barely positive with 18 up/ 17 down and 0 flat at the mid-day, ending with a positive close of 18 incliners, 14 decliners and 0 flat
  • Monday’s advance/decline line opened positive at 20 up/ 14 down and 1 flat, stayed positive with 25 up/ 10 down and 0 flat at the mid-day, ending with a positive close of 23 incliners, 12 decliners and 0 flat


Ebb and flow:

Q3: September – 1 holiday, 5 positive and 2 negative closes

·         August – 9 positive and 14 negative closes

·          July - 1 holiday, 12 positive and 8 negative close


Key Metrics:

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

  • Tuesday, the IBB was down -0.16% and the XBI was up +0.38%
  • Monday, the IBB was up +0.65% and the XBI was up +0.22%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was up +0.44 point or +3.19% at 14.24
  • Monday was up +0.05 point or +0.36% at 13.90


Closing Down (10 of 14):

  • Intellia Therapeutics (NTLA -$1.10 after Monday’s +$0.38),
  • Blueprint Medicine (BPMC -$0.74 after Monday’s +$0.43),
  • CRISPR Therapeutics (CRSP -$0.70 after Monday’s +$1.13),
  • Generation bio (GBIO) -$0.50),
  • uniQure NV (QURE -$0.34),
  • Caribou Biosciences (CRBU -$0.29 after Monday’s +$0.63),
  • Voyager Therapeutics (VYGR -$0.25 after Monday’s -$0.32),
  • MiMedx (MDXG -$0.21),
  • AxoGen (AXGN -$0.17),
  • Editas Medicine (EDIT -$0.17),

FLAT (3):

  • Brainstorm Cell Therapeutics (BCLI)
  • Homology Medicine (FIXX)
  • Mesoblast (MESO)

Closing Up (10 of 18):

  • Alnylam Pharmaceuticals (ALNY +$7.93 after Monday’s +$2.29),
  • Vericel (VCEL +$2.46 after Monday’s +$1.35),
  • Ionis Pharmaceuticals (IONS +$2.22),
  • Sage Therapeutics (SAGE +$1.79),
  • Harvard Apparatus RN (HRGN +$0.88),
  • Ultragenyx Pharmaceuticals (RARE +$0.67 after Monday’s -$0.41),
  • Verve Therapeutics (VERV +$0.39 after Monday’s +$0.36),
  • BioLife Solutions (BLFS +$0.24),
  • Prime Medicine (PRMC +$0.24 after Monday’s +$1.35),
  • Fate Therapeutics (FATE +$0.10 after Monday’s -$0.04),


Q3/23 – September

  • Tuesday closed positive with 18 incliners, 14 decliners and 3 flats
  • (9/11) Monday closed positive with 23 incliners, 12 decliners and 0 flat


The BOTTOM LINE: I try to keep it simple … and short!

I follow the dictum, quoting Churchill that “short words are best, and the old words when short are best of all.”

My version of the morning’s “indications” is about what you need to know; it’s what could happen or materialize after the opening and what might happen during the session


Investors are in a holding pattern waiting to understand inflation reporting the labor market, prices and consumer demand and the resulting Fed policy.

Tomorrow, the focus turns to Consumer Price Index (CPI) inflation data due for release on Wednesday.

This week's clutch of economic data will be weighed for its potential to influence the Fed at its upcoming September meeting. Investors are assessing whether more interest rate hikes remain on the table, and if so, whether they've been priced into the stock market.


Another reiteration, “too many factors are calling the ball on share pricing – sentiment, economics, upcoming Q3 earnings, and I believe the political aspect of the country’s leanings, polarization, and disparities of the debt ceilings arguments are suppressing some share pricing actions.”

The cell and gene therapy sector equity stayed positive after Monday’s positive close Friday’s positive close, Thursday’s negative close, Wednesday’s positive close following last Tuesday’s dive.


The “rats” are leaving the ship: Nick Leschly, CEO departs bluebird Bio (BLUE) spinout amid restructuring and layoffs …

Some two years after splitting … bluebird Bio (BLUE) into two (2) entities in a bid to “sharpen their focus” and improve operations, the spinout focused on oncology treatments announced major cost cuts and is parting ways with its chief executive.

The spinout, 2Seventy Bio (TSVT) announced Tuesday that it is cutting approximately 40% of its workforce, or about 176 employees.

It also plans to allocate less money to a couple of drug candidates, including one that is currently on hold with the FDA. The cuts extend the company’s cash runway into 2026. <STAT news>


Some good news:  Cambridge, Mass. Rome Therapeutics Inc. (private) has brought on Johnson & Johnson (JNJ) and Bristol Myers Squibb Co. (BMY) as new investors in a $72 million extension to its Series B venture capital round.

ROME Therapeutics, hopes to illuminate the dark genome to pioneer a new approach to treating serious diseases. For decades, drug discovery has focused on just 2% of the human genome. The remaining 98% is known as the dark genome: vast regions of underexplored territory and untapped therapeutic opportunity to develop breakthrough treatments for people with cancer, debilitating autoimmune diseases.

The dark genome consists of long stretches of DNA outside of the genes that encode traditional proteins. The majority of the dark genome is comprised of repetitive elements, or genomic repeats.


Right up front, “I also hate to be so negative or contrarian but, this is a NO spin zone and truth is its product; I can always be WRONG but … I am mostly EARLY!”

Being “greedy when others are fearful” is easier said than done

When a cell and gene therapy sector equity sells-off to or below a buy point, investors face a tough decision: hold tight, exit or trim the position. There's not necessarily a "right" answer. Sometimes the stock will bounce right back, others will keep falling — perhaps after briefly bouncing. A more-cautious approach may make more sense in the current volatile market.


The top three (3) performing in the session:

Tuesday: Alnylam Pharmaceuticals (ALNY) - again, Vericel (VCEL) and Ionis Pharmaceutrals (IONS)

Monday: Alnylam Pharmaceuticals (ALNY), CRISPR Therapeutics (CRSP), Prime Medicine (PRMC)


While The worst three (3) in the session:

Tuesday: Intellia Therapeutics (NTLA), Blueprint Medicines (BPMC) and CRISPR Therapeutics (CRSP)

Monday: Voyager Therapeutics (VYGR), Brainstorm Cell Therapeutics (BCLI) and Adverum Biotechnologies (ADVM)


I am definitely considered a contrarian depending on the session – one has to be a watcher of the ups and downs as well as measurer of sentiment. I am also a NO trust investor but, a validate and verify journalist/analyst.

The NO spin zone! U.S. public shareholders deserve accountability …


Harvard Apparatus Regenerative Technology (HRGN) formerly Biostage (OTCQB: BSTG) … as of 7/20/23 -- so many issues according to the 8-K and 10-K!     

Still labeled a … Going Concern

·         HRGN has incurred substantial operating losses since its inception, and as of June 30, 2023 had an accumulated deficit of approximately $88.5 million and will require additional financing to fund future operations.

·         HRGN will NEED to raise additional funds to fund its operations. WHO and WHICH U.S. investors would INVEST in a BASICALLY Chinese company with their history??

·         As they continue pumping the price “pump share pricing and promote volume” just like a Ponzi scheme???


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.