December 5, 2023 4:47pm

As I had written: We're in a period of sector rotation, and people are trying to figure out what cell and gene therapy sector equities at are going to continue to do well and what are the stocks that are going to suffer” and the “rise in risky equities’ share pricing knowing that bad things can happen?”

RegMed Investors (RMi) Research Note: Harvard Apparatus Regenerative Medicine (OTCQB: HRGN). The Bottom Line: Even lipstick will NOT help this pig, even with a press release, FDA will not allow another trial until the current is completed in 3-5 years!

Pre-open Indications: 6 Hits and 2 Miss

Subscription is coming, it is not conscription but, an offer to join our collective of like-minded investors!  Join me … in the NO spin zone.

Never leave an investor uninformed!

After careful examination of the sector and breathe trends, I STILL come away more cautious. Having lived through the rise and multiple declines of “our” universe’s stock price.

Investors must be better informed on what fluctuating economics and markets can do to an equity, or what impact indications or expectations can have.


I also won’t apologize for being a “Devil’s Advocate” challenging views or consensus by building the “thesis” for today’s actions


The Dow closed DOWN -79.88 points or -0.22%, the S&P closed DOWN -2.60 points or -0.06% while the Nasdaq closed barely UP +44.42 points or +0.31%



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 with the Dow and S&P slipping for a second day on Tuesday …

Tuesday’s moves follow Monday’s losing session for all three indexes, which called into question whether the market had run up too far too fast. Monday’s pullback came on the heels of five consecutive positive weeks for the three major averages. <CNBC>

Economic Data Docket: Job openings tumbled in October to their lowest in 2½ years, a sign the historically tight labor market could be loosening. Job openings totaled 8.73 million for the month, a decline of 617,000, or 6.6%, the Labor Department reported Tuesday in its monthly JOLTS report. That was the lowest total since March 2021 and brought the ratio of openings to available workers down to 1.2 to 1.

  • The biggest sector decline was education and health services (-238,000), followed by financial activities (-217,000), leisure and hospitality (-136,000), and retail (-102,000)


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

  • Tuesday’s advance/decline line was negative with 2 incliners, 31 decliners and 2 flats at the open, the mid-day stayed negative with 4 incliners, 31 decliners and 0 flat, ending with a negative close of 5 incliners, 29 decliners and 1 flat
  • Monday’s advance/decline line was positive at the open with 25 incliners, 6 decliners and 4 flats, flopped negative with 22 decliners/12 incliners and 1 flat springing positive at the mid-day with 25 declined, 8 incliners and 2 flats, ending with a positive close of 26 incliners, 8 decliners and 1 flat


Pre-open Indications: 6 Hits < Alnylam Pharmaceuticals (ALNY -$2.21), BioLife Solutions (BLFS -$0.45), Caribou Biosciences (CRBU -$0.04),  Ultragenyx Pharmaceuticals (RARE +$0.81), Blueprint Medicine (BPMC +$0.78), Sage Therapeutics (SAGE -$0.02)> and 2 Miss < CRISPR Therapeutics (CRSP -$1.40), Verve Therapeutics (VERV -$0.46)>


Ebb and flow of MY covered sector cell and gene therapy session daily “endings”:

Q4:  December – 1 negative and 2 positive closes

  • November – 11 positives, 1 holiday and 10 negative closes
  • October – 12 negative and 10 positive closes


Key Metrics:

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

  • Tuesday, the IBB was down -0.40% and the XBI was down -0.49%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was down -0.23 point or -1.76% at 12.63


Tuesday’s Closing Down (10 of 29):

  • Alnylam Pharmaceuticals (ALNY -$2.50 after Monday’s +$1.36),
  • Ionis Pharmaceuticals (IONS -$1.46 after Monday’s -$0.17),
  • Beam Therapeutics (BEAM -$1.31 after Monday’s -$0.01
  • Vericel (VCEL -$0.93 after Monday’s +$0.41),
  • CRISPR Therapeutics (CRSP -$0.91 after Monday’s +$2.86
  • BioLife Solutions (BLFS -$0.58 after Monday’s +$0.62),
  • Verve Therapeutics (VERV -$0.44),
  • Regenxbio (RGNX -$0.39 after Monday’s+$0.34),
  • uniQure NV (QURE -$0.37 after Monday’s -$0.04),
  • Prime Medicine (PRME -$0.22)

Flat (1)

  • Precigen (PGEN),

Tuesday’s Closing Up (5 of 5):

  • Ultragenyx Pharmaceuticals (RARE +$0.79 after Monday’s +$1.09),
  • Blueprint Medicine (BPMC +$0.59 after Monday’s +$0.70)
  • Solid Biosciences (SLDM +$0.31 after Monday’s +$0.52),
  • Graphite (GRPH +$0.02)
  • Adverum Biotechnologies (ADVM +$0.0039),


Q4/23 – December

  • Tuesday closed negative with 5 incliners, 29 decliners and 1 flat
  • Monday closed positive with 26 incliners, 8 decliners and 2 flats
  • Friday closed positive with 30 incliners, 3 decliners and 2 flats


The BOTTOM LINE: I am sticking to/with - November euphoria gives way to December doubts!

  • “I remain a skeptic, thus maintaining; investors should consider getting defensive” … if dead wood or too struggling share pricings are in the portfolio; especially those desperately needing a financing, lacking a partner, restructuring and needing a financing or just wallowing in the market
  • And from Monday: “As November ended <and December began>, investors should punch out some sector equities or buy up some bottom liners.
  • Reiterating, “Investors NEED to start formulating their portfolio outlook into next year.”
  • What did I write last night.: what are we riding the merry-go-round.
  • What has changed, just those who are up and down swapping roles …
  • I STILL believe some cell and gene therapy sector upsiders are … overbought.
  • I also DON’T TRUST totally in the THIS market -- it’s usually a signal to lighten the load of the sector’s upside movers.
  • Being that I have concerns over the upside moves that usually end in downward sells as the risk/reward profile doesn’t always compel elevated and “dramatic” i.e., sudden equity pricing.


It might be prudent to harvest and cash in some chips following the past month’s dramatic rally.


Betrayal of managements, investors and employees:

  • ReNAgade Therapeutics (private) focuses on the boundless potential of RNA therapeutics to treat disease in Cambridge, Massachusetts: is laying off 10% of its team.  The biotech launched six months ago after raising a $300M series A (MPM and F2 Ventures), one of the largest private financings of the year.

What’s behind the numbers:

  • Benchmark 10-year note yields were last pegged at 4.178%, down near 13 basis points from Monday levels, while 2-year notes were pegged at 4.608%.
  • Investor sentiment, which was rattled by Monday's sharp move higher in Treasury bond yields, took another hit overnight. That's when Moody's Investors Service lowered its outlook on China's A1 credit rating, citing risks liked to property and local government debt alongside "persistently lower medium-term economic growth." <The Street>
  • U.S. job openings dropped in October to the lowest level since early 2021, indicating that the labor market was easing as higher interest rates cool demand in the economy.
  • Other data indicated the U.S. services sector picked up steam in November as business activity increased, although new orders were flat and a gauge of input inflation slipped. <Yahoo Finance>
  • It's time to think ahead to December. It's usually an important month for the Nasdaq.
  • Don’t FORGET portfolio December tax selling and a bit of rebalancing
  • And then comes January and with worries that the U.S. economy will be slowing down, the potential for continued Middle East violence and, of course, the real prospect of bitterly contested elections across all of the United States. <The Street>

The top three (3) performing in the session:

  • Tuesday: Alnylam Pharmaceuticals (ALNY) – 2x, and Ionis Pharmaceuticals (IONS) -2x and Beam Therapeutics (BEAM)
  • Monday: CRISPR Therapeutics (CRSP), Alnylam Pharmaceuticals (ALNY) and Ultragenyx Pharmaceuticals (RARE)

The worst three (3) in the session:

  • Tuesday: Ultragenyx Pharmaceuticals (RARE), Blueprint Medicine (BPMC) and Solid Biosciences (SLDB)
  • Monday: Ionis Pharmaceuticals (IONS), Cellectis SA (CLLS) and Fate Therapeutics (FATE)


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

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


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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.

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