August 7, 2023 4:44pm

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Pre-Open Indications: 1 Hit

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The Dow closed UP +407.51 points (+1.16%), the S&P closed UP +40.41 points (+0.90%) while the Nasdaq closed UP +85.16 points (+0.61%)

 

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 jumped as the cell and gene therapy sector dived deep into its newest low after more earnings and Sage Therapeutics (SAGE) and Biogen (BIIB) FDA split decision on a post-partum depression drug.

Both the Nasdaq and the S&P 500 ended four-day losing streaks.

An appropriate quote, “Markets are back on to a risk-on mode,” said Chris Zaccarelli, chief investment officer of the Independent Advisor Alliance. “It’s been a better-than-expected earnings season, and so I think that’s why the market’s had such staying power.” <CNBC>

Economic Data Docket: brace for - consumer and producer price index data given their connection to the path of inflation and the health of the economy.

 

Monday (8/7) … RegMed Investors’ (RMi) pre-open: “after a losing week.  Earnings are still a non-stimulus as investors shift focus to the release of July consumer and producer price index data later in the week … https://www.regmedinvestors.com/articles/13066   

RegMed Investors (RMi) Research Note: 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: 1 Hit < Sage Therapeutics Agenus (SAGE -$18.45), and 0 Miss

 

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 2 up/ 30 down and 3 flats, stayed negative with 4 up/ 30 down and 1 flat at the mid-day, ending with a negative close of 2 incliners, 31 decliners and 2 flats
  • Friday’s advance/decline line opened positive at 16 up/ 15 down and 4 flats, strayed negative with 16 up/ 17 down and 2 flats at the mid-day, ending with a negative close of 12 incliners, 22 decliners and 1 flat

 

Key Metrics:

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

  • Monday, the IBB was down -0.63% and the XBI was down -3.11%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was down -1.25 point or -7.31% at 15.85

 

 

Closing Down (10 of 31):

  • Sage Therapeutics (SAGE -$19.35 after Friday’s +$0.09),
  • Blueprint Medicine (BPMC -$2.70 after Friday’s -$1.03),
  • CRISPR Therapeutics (CRSP -$2.62 after Friday’s -$0.39),
  • Verve Therapeutics (VERV -$2.61 after Friday’s +$0.03),
  • Beam Therapeutics (BEAM -$1.58),
  • Ultragenyx (RARE -$1.53 after Friday’s -$3.63),
  • Alnylam Pharmaceuticals (ALNY -$1.29 after Friday’s -$4.52)
  • Prime Medicine (PRMC -$1.19),
  • Ionis Pharmaceuticals (IONS -$0.62),
  • Editas Medicine (EDIT -$0.62),

Flat (1):

  • Harvard Apparatus RM (HNGN) – formerly BIostage (BSTG)

Closing Up (2 of 2):

  • Precigen (PGEN +$0.03),
  • Bellicum Pharmaceuticals (BLCM +$0.0050 After Friday’s +$0.0065)

 

Q3/23 – August

  • Monday closed negative with 2 incliners, 31 decliners and 2 flats
  • Friday closed negative with 12 incliners, 22 decliners and 1 flat

 

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 colling since 8/1 … as Q2/23 earnings LPS (loss-per-share) get released

 

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:

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

Friday: Intellia therapeutics (NTLA), BioLife Solutions (BLFS) and Ionis Pharmaceuticals (IONS)

 

While The worst three (3) in the session:

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

Friday: Alnylam Pharmaceuticals (ALNY), Ultragenyx (RARE) and Mesoblast (MESO)

 

Sector Pain and Agonies:

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 (ticker: 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

Today:

8/7 – Sage Therapeutics (SAGE) – a net loss of -$160.3 M or -$2.68 per share with a cash position of $1 B and a runway until 2025

Net loss, per-share consensus and revenue misses

 

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.

 

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.