September 7, 2023 4:40pm

A little bit of Nietzsche’s aphorism/quote (in my definition) “The meaning of the abyss is less obvious, but investors must gain the strength to stare past the downslides including its current origin, its constraints, and to gain greater control over our portfolios without eroding our value, our exactitudes that elevates our holdings from the abyss

Pre-open Indications: 7 Hits and 3 Miss

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Never leave an investor uninformed! 

If I have learned one thing as a former research analyst in a closed end -venture and public equity funds, multiple operating roles, x-military officer and x-FBI, an adjunct (MBA) business school professor now a journalist; my life and your portfolio are largely tied to our knowledge of the biotech universe’s patterns, price movements and questioning pricing targets.


The Dow closed UP +57.54 points or +0.17%, the S&P closed DOWN -14.34 points or -0.32% while the Nasdaq closed DOWN -123.64 points or -0.89%



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 were mixed to the close.

The S&P 500 and Nasdaq dived Thursday as renewed concern over the Fed’s interest rate policy path, and whether policymakers will enact another hike this year.

A series of economic data points Thursday — including fewer-than-expected jobless claims — contributed to fears.

Economic Data Docket: Jobless claims came in at 216,000, versus the 230,000 expected by Dow Jones, while labor costs rose more than anticipated.

·         A separate report from the Bureau of Labor Statistics showed that unit labor costs, a calculation of hourly compensation minus productivity, increased 2.2% in the second quarter, higher than the 1.9% estimate.

·         Nonfarm productivity, or output per hour, increased 3.5% for the quarter, a 0.2 percentage point downward revision but 0.1 percentage point above the forecast, the BLS said.

·         Fewer-than-expected jobless claims, further prompted concerns that the still strong labor market may make the Fed think twice about relaxing its tight monetary policy.


Thursday (9/7) … RegMed Investors’ (RMi) Opening Bell: “Hope is not a good investment strategy. Skim if you can trim, buy if it will fly and sell if compelled!” …


Pre-Open indications: 7 Hits < Beam Therapeutics (BEAM +$0.49), BioLife Solutions (BLFS -$0.83), Blueprint Medicine (BPMC +$0.60), CRISPR Therapeutics (CRSP -$1.75), Ionis Pharmaceuticals (IONS +$0.59), Sage Therapeutics (SAGE +$0.25), Ultragenyx Pharmaceuticals (RARE +$2.35)> and 3 Miss < Alnylam Pharmaceuticals (ALNY -$0.35), Intellia Therapeutics (NTLA -$0.50), Verve Therapeutics (VERV -$0.06)>  


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

  • Thursday’s advance/decline line opened negative at 6 up/ 27 down and 2 flats, stayed negative with 9 up/ 23 down and 3 flats at the mid-day, ending with a negative close of 8 incliners, 24 decliners and 3 flats


Ebb and flow:

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

·         August – 9 positive and 14 negative closes

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


52-week low:

  • Solid Biosciences (SLDB)
  • Verve Therapeutics (VERV)
  • Fate Therapeutics (FATE)


Key Metrics:

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

  • Thursday, the IBB was down -0.34% and the XBI was down -1.43%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Thursday was neutral +0.00 point or 0.00% at 14.45


Closing Down (10 of 24):

  • CRISPR Therapeutics (CRSP -$1.75 after Wednesday’s +$0.83 and Tuesday’s -$0.27),
  • BioLife Solutions (BLFS -$0.83),
  • Vericel (VCEL -$0.64 after Wednesday’s +$0.97 and Tuesday’s -$1.32),
  • Intellia Therapeutics (NTLA -$0.50 after Wednesday’s +$0.22 and Tuesday’s +$0.28),
  • Alnylam Pharmaceuticals (ALNY -$0.35 after Wednesday’s +$1.11 and Tuesday’s -$0.83),
  • Caribou Biosciences (CRBU -$0.32 after Wednesday’s -$0.11 and Tuesday’s +$0.34),
  • Regenxbio (RGNX -$0.30 after Wednesday’s +$0.23 and Tuesday’s -$0.69),
  • Bluebird bio (BLUE -$0.27),
  • AxoGen (AXGN -$0.24),
  • Editas Medicine (EDIT -$0.21 after Wednesday’s +$0.29),

Flat (3);

  • Harvard Apparatus GN (HRGN)
  • Bellicum Pharmaceuticals (BLCM)
  • Cellectis SA (CLLS)

Closing Up (8 of 8):

  • Ultragenyx Pharmaceuticals (RARE +$2.35 after Wednesday’s +$0.76 and Tuesday’s +$0.25),
  • Blueprint Medicine (BPMC +$0.60 after Wednesday’s +$0.36 and Tuesday’s -$0.95),
  • Ionis Pharmaceuticals (IONS +$0.59 after Wednesday’s +$0.45 and Tuesday’s -$1.16),
  • Beam Therapeutics (BEAM +$0.49 after Wednesday’s +$0.98 and Tuesday’s +$0.22),
  • Prime Medicine (PRMC +$0.41 after Wednesday’s -$0.09 and Tuesday’s -$0.78),
  • Sage Therapeutics (SAGE +$0.25),
  • Adverum Biotechnologies (ADVM +$0.02)
  • Granite BIUO (GRPH +$0.01)


Q3/23 – September

  • Thursday closed negative with 10 incliners, 23 decliners and 2 flats


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.”

The S&P 500 and Nasdaq fell on Thursday, with the weakness in chip stocks over concerns about China's iPhone curbs, while a fall in weekly U.S. jobless claims fed worries about interest rates and sticky inflation.

A U.S. Labor Department report showed the number of Americans filing for unemployment claims fell to 216,000 for the week ended Sept. 2, hitting the lowest level since February.

Investors uncertain about the Fed's path for interest rates awaited inflation readings from August, due out in a week.


Cell and gene therapy sector stocks sold off on Thursday continuing the sluggish start to September, as concerns mounted that the Fed may not be done hiking interest rates.

The cell and gene therapy sector equity closed negative on Thursday after its positive on Wednesday following Tuesday’s dive post Friday’s positive close; the previous Monday was a holiday with the come-back a glaring downslide - leading with light trading volumes.


More bad news, another crash:  Lexington-based iSpecimen (ISPC-$0.0016 to $0.65) an online global marketplace that connects scientists requiring biospecimens for medical research with a network of healthcare specimen providers, announced that the Board of Directors has approved an organizational restructuring plan to improve operational performance and drive shareholder value.

·         ISPC announced immediate headcount reductions of approximately 20% of the Company’s total workforce and additional expense reductions after streamlining operations and rationalizing resources to focus on key market opportunities.

·         Christopher Ianelli - founder, left the company in October 2022. A year later, several others are following him out the door amid operational changes.

·         Six (6) more people were (Wednesday) let go


WHY these quotes, it’s about retail investors and … financing the sector – it ain’t good, actually downright bad!


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:

Thursday: Ultragenyx Pharmaceuticals (RARE), Blueprint Medicine (BPMC) and Ionis Pharmaceutrals (IONS)

Wednesday: Alnylam Pharmaceuticals (ALNY), Beam Therapeutics (BEAM) and Vericel (VCEL)

Tuesday: Intellia Therapeutics (NTLA), Caribou Biosciences (CRBU) and Sage Therapeutics (SAGE)

Monday was a holiday


While The worst three (3) in the session:

Thursday: CRISPR Therapeutics (CRSP), BioLife Solutions (BLFS) and Vericel (VCEL)

Wednesday: Verve Therapeutics (VERV), Brainstorm Cell Therapeutics (BCLI) and Fate Therapeutics (FATE)

Tuesday: Ionis Pharmaceuticals (IONS), Blueprint Medicine (BPMC) and Vericel (VCEL)

Monday was a holiday


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!

•              Accumulated deficit:  $88.5 M (newest 10-K)

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??

·         Are they back pumping the price +$0.01 and volume – as 5,757 shares traded – reinforcing MY view as a Ponzi scheme!! <9/5/23>. Funny how so many and Thursday and Wednesday’s flats surrounding the “pop” on Tuesday


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.