August 9, 2023 5:35pm

Pre-Open Indications: 4 Hit and 1 Miss (I stick yesterday’s forecast even after slippage!)

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If I have learned one thing as a former research analyst in a venture and public fund, operating executive, 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 price movements and questioning pricing targets.

 

The Dow closed DOWN -191.13 or -0.54%, the S&P closed DOWN -31.67 or -0.70% while the Nasdaq closed DOWN -162.32 points (-1.17%)

 

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 fell Wednesday awaiting fresh inflation data coming later in the week.

An honest quote, ““Markets are focused on whether or not inflation is falling fast enough to allow the Fed to stop hiking rates,” said Bill Merz, head of capital markets research at U.S. Bank Wealth Management. “It has been decelerating, but it’s still too high. And the Fed is at a bit of a crossroads.” <CNBC>

Playing through the numbers, “The Nasdaq Composite has lost 4.4% since August began, while the S&P 500 and Dow have slid 2.6% and 1.2%, respectively. With Wednesday’s retreat, the Nasdaq has moved into negative territory on the quarter. Still, all three indexes are notably higher than where each began 2023.” < Phillip Colmar, managing partner at MRB Partners>

Economic Data Docket: an anticipated U.S. inflation report, with July’s reading of the consumer price index slated for release Thursday.

 

Wednesday (8/9) … RegMed Investors’ (RMi) pre-open: “strolling down the lane of cratered earnings sessions. If you’re looking for sector intel, ideas and facts or Insight in a volatile climate, RMi defines the extenuating factors of share pricing.” … https://www.regmedinvestors.com/articles/13070

RegMed Earnings: Q2/23 net losses earnings, cash positions and runway outcomes. LPS (loss-per-share) releases will present challenges to share pricing with outcomes included … https://www.regmedinvestors.com/articles/13058

 

Pre-Open Indications: 4 Hit < Verve Therapeutics (VERV -$0.25), Blueprint Medicine (BPMC +$0.90), Precigen (PGEN +$0.05), Ultragenyx (RARE +$0.76) and 1 Miss < Regenxbio (RGNX +0.36)

 

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

Wednesday’s advance/decline line opened negative at 15 up/ 18 down and 3 flats, strayed negative with 13 up/ 18 down and 4 flats at the mid-day, ending with a positive close of 18 incliners, 16 decliners and 1 flat

 

Key Metrics:

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

Wednesday, the IBB was up +0.42% and the XBI was down -0.09%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Wednesday was down -0.03 point or -0.19% at 15.96

 

Closing Down (10 of 16):

  • BioLife Solutions (BLFS -$5,28 after Tuesday's-$0.25),
  • CRISPR Therapeutics (CRSP +$2.10 after Monday’s -$2.62)
  • Vericel (VCEL -$0.64 after Tuesday's +$0.90),
  • bluebird Bio (BLUE -$0.35 after Tuesday's -$0.19),
  • Harvard Apparatus GN (HRGN -$0.20),
  • Generation Bio (GBIO -$0.19),
  • Mesoblast (MESO -$0.14 after Tuesday’s -$0.04),
  • Beam Therapeutics (BEAM -$0.14 after Monday’s -$1.58),
  • Fate Therapeutics (FATE -$0.13),
  • Solid Biosciences (SLDB -$0.11),
  • Sangamo Therapeutics (SGMO -$0.09),

Flat (1):

  • Adverum Biotechnologies (ADVM)

Closing Up (10 of 18):

  • Ultragenyx (RARE +$1.64 after Monday’s -$1.53),
  • Alnylam Pharmaceuticals (ALNY +$0.55 after Monday’s -$1.29)
  • Blueprint Medicine (BPMC +$0.24 after Monday’s -$2.70),
  • Ionis Pharmaceuticals (IONS +$0.43 after Monday’s -$0.62
  • Caribou Bioscience (CRBU -$0.04),
  • Regenxbio (RGNX +$0.30)
  • Voyager Therapeutics (VYGR +$0.16),
  • Compass Therapeutics (CMPX +$0.15),
  • MiMedx (MDXG -$0.12),
  • Precigen (PGEN +$),

 

Q3/23 – August

  • Wednesday closed positive with 18 incliners, 16 decliners and 1 flat
  • Tuesday closed positive with 20 incliners, 15 decliners and 0 flat
  • Monday closed negative with 2 incliners, 31 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 sector froze after cooling since 8/1 … as Q2/23 earnings LPS (loss-per-share) get released

“U.S. indexes closed lower, on Wednesday, the day after a report showed Americans borrowed more than ever on their credit cards in the last quarter, and a day ahead of U.S. Consumer Price Index (CPI) inflation data that could influence Federal Reserve interest rate decisions.” <Reuters>

August tends to frighten many stock market investors and historians.

·         The stock market is riding high after a strong performance in July, but August could be a difficult month for investors.

·         Data compiled by the Stock Trader’s Almanac shows the S&P 500 averages just a 0.1% gain in August. That makes it the third-worst month on average for the benchmark index. The Dow, meanwhile, averages a loss of 0.04% in August. <CNBC>

Cell and gene therapy sector performance continues to suggest the results of earning season.

 

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!”

 

The top three (3) performing in the session:

Wednesday: Ultragenyx (RARE), Alnylam Pharmaceuticals (ALNY) – again, and Blueprint medicine (BLMC)

Tuesday: CRISPR Therapeutics (CRSP), Sage Therapeutics (SAGE) and Alnylam Pharmaceuticals (ALNY)

Monday: Solid Biosciences (SLDB), Precigen (PGEN) and Bellicum Pharmaceuticals (BLCM)

 

While The worst three (3) in the session:

Wednesday: BioLife Solutions (BLFS) – again, CRISPR Therapeutics (CRSP), and Vericel (VCEL0

Tuesday: AxoGen (AXGN), Ultragenyx (RARE) and

Monday: Sage Therapeutics (SAGE) and Bellicum Pharmaceuticals (BLCM)

 

Sector Pain and Agonies: continues with SAGE rebounding Wednesday’s +$0.06 to $18.99 after Tuesday’s +$1.89 or +11.28 to $18.64

A split FDA decision on a new depression medicine from Sage Therapeutics (SAGE –53.60%) and Biogen (BIIB +0.86%) blew holes in the strategies of both companies and raised questions about the future of their collaboration.

Late on Friday, the FDA approved a two-week course of the pill Zurzuvae as a treatment for postpartum depression, but not for major depressive disorder.

·         Zurzuvae is the first oral treatment, and the second medicine, ever approved specifically for postpartum depression.

·         The major depressive disorder indication, however, is far larger, and investors had expected roughly two-thirds of the drug’s sales to come from those prescriptions.

The rejection of the major depressive disorder indication appears to be a major setback for Sage and shares of the biotech were down 50% on Monday morning. The news is bad for Biogen (BIIB) as well, though it seems to have been largely anticipated by investors. <Barron’s)

 

RegMed Investors (RMi) Research Note: Q2/2023 earnings reporting date announcements … https://www.regmedinvestors.com/articles/13044

 

Good News Post Earnings’: CRISPR Therapeutics (CRSP) j having topped consensus estimate jumped +$4,76 or 9.85% as of after rising as much as 13% earlier in the day. CRISP reported Q2 revenue of $70 million. Credit Suisse's Richard Law reiterated a neutral rating for the gene-editing stock but increased his price target from $62 to $63.

 

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!

·         Question: is HRGN just another Ponzi scheme (with their pump/promote buy and sell agenda) as shares are bought to replace those sold?

·         Accumulated deficit:  $85,901 M

·         Will HRGN ESCAPE the scandals when its “former” corporate name was used by a former chairman and CEO Green initiating scandal plagued utilization of an Italian surgeon and the $5 M it took to settle out the executive responsibility as it was SHIFTED to the company shareholders and Harvard Bio (HBIO)???

·         Can this management team be TRUSTED by ANY shareholder other then major holders’ Chinese off-shore investors.

·         HRGN dived -$0.20 with 2946 shares traded – is DST back trying to FIX a falling entity AKA, a Ponzi/Madoff scheme???

 

My question that resounds, that should be asked is how many companies are at the end of sentiments …  leash?

 

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.