September 18, 2023 4:48pm

Food inflation, staples of life, rising gas prices, a possible government shutdown in less than 2 weeks, the UAW strike enters its 4th day, resumption of student loan payments begins pointing to slower economic growth which has destabilized sentiment while Q3 LPS (loss-per-share) earnings initiate in October – 10 sessions from today

Pre-open Indications: 2 Hits and 2 Miss

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The Dow closed UP +6.06 points or +0.02%, the S&P closed UP +3.21 points or +0.07% while the Nasdaq closed UP +1.90 points or +0.01%



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 closed barely up as investors geared up for the Fed policy/rate meeting scheduled for later in the week.

Economic Data Docket: Home building confidence index falls to five-month low amid high mortgage rates. Buyers are struggling with rates over 7% and are choosing to wait until they drop, which pushed the National Association of Home Builders’ monthly confidence index down 5 points to 45 in September,


Monday (9/18) … RegMed Investors’ (RMi) Opening Bell: “who has a share pricing compass or even a barometer? Looking toward the Fed’s next policy decision; last week ended as the sector ended with three (3) positive and two (2) negative closes.” …


Pre-Open indications: 2 Hits < Caribou Biosciences (CRBU -$0.61), CRISPR Therapeutics (CRSP -$2.94)> and 2 Miss <Alnylam Pharmaceuticals (ALNY -$5.22), Ultragenyx Pharmaceuticals (RARE -$1.37)>


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

  • Monday’s advance/decline line opened negative at 9 up/ 25 down and 1 flat, stayed negative with 8 up/ 26 down and 1 flat at the mid-day, ending with a negative close of 11 incliners, 22 decliners and 2 flats
  • Friday’s advance/decline line opened positive at 9 up/ 24 down and 3 flats, flipped negative at the mid-day with 6 up/ 27 down and 2 flats, ending with a negative close of 8 incliners, 25 decliners and 2 flats


Ebb and flow:

Q3: September – 1 holiday, 6 positive and 5 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:

  • Monday, the IBB was down -1.07% and the XBI was down -1.50%
  • Friday, the IBB was down -0.76% and the XBI was down -1.47%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +0.29 point or +2.10% at 14.08
  • Friday was up +1.09 point or -8.50% at 13.91


Closing Down (10 of 22):

  • Alnylam Pharmaceuticals (ALNY -$5.22 after Friday’s -$8.07)
  • CRISPR Therapeutics (CRSP -$2.94 after Friday’s -$0.70),
  • Ultragenyx Pharmaceuticals (RARE -$1.37 after Friday’s -$1.58),
  • Intellia Therapeutics (NTLA -$0.80),
  • Beam Therapeutics (BEAM -$0.74),
  • Sage Therapeutics (SAGE -$0.72 after Friday’s -$0.47),
  • Caribou Biosciences (CRBU -$0.61 after Friday’s +$0.21),
  • uniQure NV (QURE -$0.57 after Friday’s +$0.26),
  • Prime Medicine (PRMC -$0.44 after Friday’s -$0.30),
  • Editas Medicine (EDIT -$0.38),

Flat (2):

  • Harvard Apparatus RN (HRGN)
  • Mesoblast (MESO)

Closing Up (11 of 11):

  • Blueprint Medicine (BPMC +$1.57 after Friday’s -$0.75),
  • Fate Therapeutics (FATE +$0.35),
  • Voyager Therapeutics (VYGR +$0.19),
  • Graphite Bio (GRPH +$0.09 after Friday’s +$0.08),
  • Bellicum Pharmaceuticals (BLCM +$0.05),
  • Brainstorm Cell Therapeutics BCLI +$0.03),
  • MiMedx (MDXG +$0.03),
  • Homology Medicine (FIXX +$0.03),
  • Verve Therapeutics (VERV +$0.03),
  • Regenxbio (RGNX +$0.03 after Friday’s -$0.30)
  • Ionis Pharmaceuticals (IONS +$0.02 after Friday’s -$0.73),


Q3/23 – September

  • Monday closed negative with 11 incliners, 22 decliners and 2 flats
  • Friday closed negative with 8 incliners, 25 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.”

As I wrote this a.m., “The Strange Case of Dr. Jekyll and Mr. Hyde might make for a great read, but it’s far less fun when the sector act like it’s their blueprint. Stocks have lately been alternating between the horrific and the benign.”


Contributing to today’s (9/18) downdraft …

Markets weakened as traders and investors are unsure ahead of the Fed's meeting this week on Tuesday and Wednesday.

While volume fell on the NYSE and the Nasdaq versus Friday’s trading was heavy due to witching options and futures expirations.

The cell and gene therapy sector equities dived again on Monday even further than Friday after popping positive on Thursday, having dived negative on Wednesday, stayed positive on Tuesday after last Monday’s positive close.


Another updating, too many factors are calling the ball on share pricing – algorithms and electronic trading, here and there sentiment, economics, upcoming Q3 earnings.

I believe the political aspect of the country’s leanings, polarization, and disparities of the debt ceilings arguments are contributing to the roller coaster ride for share pricing actions.


It’s still about the economy … STUPID as investors congest a raft of economic reports pointing to … tamer core inflation data and a spending consumer.

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:

Monday: Blueprint Medicines (BPMC), fate therapeutics (FATE) and Voyager Therapeutics (VYGR)

Friday: Caribou Biosciences (CRBU), uniQure NV (QURE) and Graphite Bio (GRPH)

While The worst three (3) in the session:

Monday: Alnylam Pharmaceuticals (ALNY) – 3x, CRISPR Therapeutics (CRSP) and Ultragenyx Pharmaceuticals (RARE) – 3x

Friday: Alnylam Pharmaceuticals (ALNY) – again, Vericel (VCEL) and Ultragenyx Pharmaceuticals (RARE) - again


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??? Notice the volume today – 5,398 shares traded <3-month average = 1,498 shares> to close FLAT?

·         Question, did you notice how it barely trades unless volume is “pump” – is it by DST, run by the president of HRGN, Hong Yu and Mrs. Mrs. bin Zhao of Weston, Mass – funded by Lui Dong Hai, chairman of Dixintong Technology Group (D. Phone, the largest smartphone retailer in China) the husband of Mrs. bin Zhao??

·         Is the current or future investment coming directly or indirectly from those associated with two (2) directors of BSTG, Jason Jing Chen (chairman of BSTG’s board of directors who resides in Beijing, China and is employed by a subsidiary of Dixintong technology Group – D. Phone), Ting Li (Donghai Securities Co., Ltd) - all reside in China – what are their affiliations??


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.