November 27, 2023 4:38pm

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Pre-Open Indications: 5 Hits and 2 Miss

News: Mesoblast Limited (MESO +$0.04) filed for orphan drug designation (ODD) and rare pediatric disease designation (RPDD) with the U.S. FDA for its allogeneic cell therapy Revascor® (rexlemestrocel-L).

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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.

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.

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

 

The Dow closed DOWN -56.68 points or -0.16%, the S&P closed DOWN -8.91 points or -0.20% while the Nasdaq closed DOWN -9.83 points or -0.07%

 

Henry’omics:

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 collapsed as the major averages missed creating a four-week winning streak.

Economic Data Docket: Investors were also looking ahead to Thursday's release of the Fed's preferred measure of inflation and euro zone consumer inflation figures, to potentially give markets direction.

 

News Continued: Mesoblast Limited (MESO; ASX: MSB). The filings were based on results from a blinded, randomized, controlled prospective trial of REVASCOR conducted at a single center in the US in 19 children with HLHS and accepted for publication in an upcoming issue of the peer reviewed The Journal of Thoracic and Cardiovascular Surgery Open (JTCVS Open).

HLHS is a severe congenital heart disease in which the left side of the heart does not fully develop and effective pumping of oxygenated blood by the left ventricle to the rest of the body is reduced. Without immediate surgery after birth, the prognosis is dismal with HLHS overall being responsible for 25% to 40% of all neonatal cardiac mortality.

 

Pre-open Indications: 5 Hits < Blueprint Medicine (BPMC +$0.67), Beam Therapeutics (BEAM -$0.51), BioLife Solutions (BLFS -$0.64), Ionis Pharmaceuticals (IONS -$0.13), Intellia Therapeutics (NTLA -$0.38)> 2 Miss < Alnylam Pharmaceuticals (ALNY -$3.72), Verve Therapeutics (VERV -$0.56)>

 

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

  • Monday’s advance/decline line was negative with 8 incliners, 26 decliners and 1 flat at the open, the mid-day continued negative with 11 declined, 22 incliners and 2 flats, ending with a negative close of 13 incliners, 22 decliners and 0 flat
  • Friday’s advance/decline line was positive with 30 incliners, 2 decliners and 3 flats at the open, the mid-day continued positive with 27 inclined, 7 decliners and 1 flat, ending with a positive close of 27 incliners, 7 decliners and 1 flat

 

Ebb and flow:

Q4:  November – 10 positive and 8 negative closes

·         October – 12 negative and 10 positive closes

 

Key Metrics:

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

  • Monday, the IBB was down -0.66% and the XBI was down -0.60%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +0.24 point or +1.93% at 12.70

 

Monday’s Closing Down (10 of 22):

  • Alnylam Pharmaceuticals (ALNY -$3.72),
  • BioLife Solutions (BLFS -$0.64 after Friday’s +$0.51),
  • Verve therapeutics (VERV -$0.56),
  • Ultragenyx Pharmaceuticals (RARE -$0.53 after Friday’s +$0.93
  • Harvard Apparatus GN (HRGN -$0.52),
  • Beam Therapeutics (BEAM -$0.51 after Friday’s +$0.20),
  • Sage Therapeutics (SAGE -$0.39),
  • Prime Medicine (PRME -$0.23),
  • Regenxbio (RGNX -$0.31 after Friday’s +$0.37
  • Intellia Therapeutics (NTLA -$0.38 after Friday’s +$0.77),

Monday’s Closing Up (13 of 13):

  • Blueprint Medicine (BPMC +$0.67 after Friday’s +$1.44
  • CRISPR Therapeutics (CRSP +$1.64 after Friday’s -$0.52
  • Vericel (VCEL +$0.34 after Friday’s +$0.17
  • Solid Biosciences (SLDB +$0.30 after Friday’s +$0.16),
  • MiMedx (MDXG +$0.26),
  • uniQure NV (QURE +$0.14),
  • Voyager Therapeutics (VYGR +$0.09 after Friday’s -$0.05),
  • Caribou BioSciences (CRBU +$0.09 after Friday’s -$0.03
  • Editas Medicine (EDIT +$0.07),
  • Mesoblast (MESO +$0.04 after Friday’s -$0.01),
  • Bellicum Pharmaceuticals (BLCM +$0.0360 after Friday’s -$0.034),
  • AxoGen (AXGN +$0.03),
  • Graphite Bio (GRPH +$0.01),

 

Q4/23 – November

  • Monday closed negative with 13 incliners, 22 decliners and 0 flat
  • Friday closed early and positive with 27 incliners, 7 decliners and 1 flat

 

The BOTTOM LINE: I was NOT wrong from Friday’s admonishment (post), “market and sector DOWNSIDE realities are inevitability as uncertainty remains under the surface.”

  • Investors NEED to start formulating their portfolio outlook into next year.

There's a noticeable that the economy is slowing, effecting share price growth that continue to fall and jockey for appreciation, as LPS (loss-per-share) cell and gene therapy companies’ earnings and “runways” highlighted the NEED to FINANCE with NO current outlook from capital markets and if they do finance the” raises” will be diminished without spectacular clinical results or partner “intervention.”   

  • After the previous week uncertain capacity and ability to stay upbeat while the sector faded, as the VIX — known as the VIX – the "fear gauge" — closed on Friday at its lowest level since January 2020; and then on Monday, the mood was downcast in the sector as the back to work “gait” followed the long Thanksgiving holiday weekend.

 

As I wrote Friday (published Saturday a.m.), “While many cell and gene therapy sector upsiders are UP, I believe … also extended; it’s usually a signal to lighten the load of the sector’s upside movers. I have concerns over the resiliency of 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.

 

What’s behind the numbers:

  • The market's three major influences – Treasury yields, oil prices and the dollar – are all moving lower Monday as markets look for near-term catalysts to extend the November rally.
  • Muted volumes in the early Monday session are keeping stocks in check,
  • Bracing for key inflation and jobs data later in the week.
  • Benchmark 10-year notes were last marked at 4.398%, with 2-year notes at 4.920%.
  • 2-year notes were trading at 4.945% ahead of a double auction of 2-year and 5-year notes.
  • A soft auction of $54 billion in new 2-year notes, which saw a big decline in foreign demand, looks to have had only a minimal impact of stocks Monday as the Treasury executes $109 billion in benchmark sales to start the week. <The Street>

 

It's time to think ahead to December. It's usually an important month for the Nasdaq.

  • Don’t FORGET portfolio 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:

  • Monday: CRISPR Therapeutics (CRSP), Blueprint Medicine (BPMC) and Vericel (VCEL)

The worst three (3) in the session:

  • Monday: Alnylam Pharmaceuticals (ALNY), BioLife Solutions (BLFS) and Verve Therapeutics (VERV) 

 

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!”

 

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.