August 18, 2023 5:07pm

Cell and gene therapy sector stocks ticked up toward the end of Friday’s trading session but remained on pace for weekly losses, as August’s struggles continue; as I had stated on Wednesday, “I’m looking at entry points”

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Markets will be on pins and needles regarding what the Fed will do all through September and into October

Week in review and what a week it has been

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 UP +25.83 or +0.07%, the S&P closed DOWN -0.65 or -0.01% while the Nasdaq closed DOWN -26.16 points (-0.20%)

 

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 closed mixed with the Dow wandering to the upside as the S&P and Nasdaq remained in the abyss.

The Dow was on pace for its worst week since March, lower by 2.6%, while, the S&P 500 is headed for a 3rd straight week of losses, a streak that hasn’t happened since February. The Nasdaq was also set for a 4th session in a row and 3rd consecutive losing week for the first time since December.

 

Friday (8/18) … RegMed Investors’ (RMi) Opening Bell: “a set-up for ending the week on a weak note” … https://www.regmedinvestors.com/articles/13084

 

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

  • Friday’s advance/decline line opened positive at 21 up/ 12 down and 1 flat, stayed positive with 20 up/ 13 down and 2 flats at the mid-day, ending with a barely positive close of 17 incliners, 16 decliners and 2 flats
  • Thursday’s advance/decline line opened negative at 7 up/ 26 down and 2 flats, stayed negative with 10 up/ 24 down and 1 flat at the mid-day, ending with a negative close of 10 incliners, 25 decliners and 0 flats
  • Wednesday’s advance/decline line opened negative at 7 up/ 27 down and 1 flat, stayed negative with 3 up/ 30 down and 2 flats at the mid-day, ending with a negative close of 6 incliners, 29 decliners and 0 flat
  • Tuesday’s advance/decline line opened negative at 6 up/ 27 down and 2 flats, flipped neutral with 17 up/ 17 down and 1 flat at the mid-day, ending with a negative close of 15 incliners, 18 decliners and 2 flats
  • Monday’s advance/decline line opened negative at 6 up/ 27 down and 2 flats, stayed negative with 11 up/ 21 down and 3 flats at the mid-day, ending with a negative close of 16 incliners, 18 decliners and 1 flat

 

Ebb and flow:

  • Q3: August – 3 positive and 11 negative closes

 

Key Metrics:

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

  • Friday, the IBB was down -0.12% and the XBI was up +0.75%
  • Thursday, the IBB was down -0.49% and the XBI was down -1.45%
  • Wednesday, the IBB was down -2.18% and the XBI was down -1.43%
  • Tuesday, the IBB was down -0.32% and the XBI was down -0.25%
  • Monday, the IBB was down -0.12% and the XBI was up +0.20%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Friday was down -0.60 point or -3.35% at 17.29
  • Thursday was up +0.97 point or +5.60% at 17.72
  • Wednesday was up +0.32 point or +1.94% at 16.78
  • Tuesday was up +1.60 point or +10.80% at 16.42
  • Monday was down -0.07 point or -0.47% at 14.77

 

Closing Down (10 of 16):

  • BioLife Solutions (BLFS -$0.73),
  • Verve Therapeutics (VERV -$0.53 after Thursday -$0.45, Wednesday’s -$0.78, Tuesday’s -$1.27 and Monday’s -$0.91),
  • Ionis Pharmaceuticals (IONS -$ after Thursday -$0.45, Wednesday’s -$0.78, Tuesday’s -$1.27 and Monday’s -$0.91),
  • AxoGen (AXGN -$0.18 after Thursday’s +$0.28, Wednesday’s -$0.51 and Tuesday’s +$0.04),
  • Beam Therapeutics (BEAM -$0.15 after Thursday’s +$0.28, Wednesday’s -$1.06, Tuesday’s -$0.95 and Monday’s -$0.33),
  • Sage Therapeutics (SAGE -$0.14 after Thursday’s -$0.36, Wednesday’s -$0.88, Tuesday’s -$0.38 and Monday’s -$0.14),
  • Precigen (PGEN -$0.11 after Thursday’s +$0.20),
  • Regenxbio (RGNX -$ o.o4 after Thursday’s -$0.31),
  • Brainstorm Cell Therapeutics (BCLI -$0.04),
  • Bellicum Pharmaceuticals (BLCM -$0.03)

 

Flat (2):

  • Compass Therapeutics (CMPX)
  • Fate therapeutics (FATE)

 

Closing Up (10 of 17):

  • Alnylam Pharmaceuticals (ALNY +$2.14 after Thursday’s +$1.46, Wednesday’s +$2.30, Tuesday’s -$1.22 and Monday’s -$4.44),
  • CRISPR Therapeutics (CRSP +$1.05),
  • Blueprint Medicine (BPMC +$0.73 after Thursday’s -$1.04, Wednesday’s -$1.85, Tuesday’s -0.19 and Monday’s +$1.88),
  • Vericel (VCEL +0.43),
  • Intellia Therapeutics (NTLA +$0.36 after Thursday’s -$0.52 and Wednesday’s -$1.06),
  • uniQure NV (QURE +$0.35 after Thursday’s -$0.19),
  • Voyager Therapeutics (VYGR +$0.22 after Thursday’s -$0.25),
  • Editas Medicine (EDIT +$0.18),
  • Ultragenyx Pharmaceuticals (RARE +$0.17 after Thursday’s -$2.20, Wednesday’s -$1.27, Tuesday’s +$0.49 and Monday’s +$1.58),
  • Agenus (AGEN +$0.15 after Thursday’s +$0.06),

 

Q3/23 – August

  • Friday closed positive with 17 incliners, 16 decliners and 2 flats
  • Thursday closed negative with 10 incliners, 25 decliners and 0 flat
  • Wednesday closed negative with 6 incliners, 28 decliners and 0 flat
  • Tuesday closed negative with 15 incliners, 18 decliners and 2 flats
  • Monday closed negative with 16 incliners, 18 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.”

It’s been a cruel summer for Nasdaq index, which is on pace for its worst Augusts since 2015 and 2001 …

Cell and gene therapy sector equity flitted with the upside on Friday to close positive after “pooping the bed” most of the week while upbeat economic data kept alive fears of interest rates remaining higher for longer.

Reiterating: bluebird bio (BLUE +$0.05) announced that the FDA has communicated that an advisory committee meeting will not be scheduled for its experimental gene therapy lovotibeglogene autotemcel (lovo-cel). BLUE is evaluating a potentially transformative one-time gene therapy, lovo-cel, for individuals living with sickle cell disease (SCD) with a proposed indication for patients ages 12 and older who have a history of vaso-occlusive events (VOEs).

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>

 

It hasn’t been a good month to report earnings…

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

30 of 35 companies have reported so far in August. The average post-report reaction to these stocks has been 100% LPS (loss-per-share) consensus with many also missing revenue forecasts.

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

 

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:

Friday: CRISPR Therapeutics (CRSP) – again, Alnylam Pharmaceuticals (ALNY) – 2x and Blueprint Medicine (BPMC)

Thursday: Alnylam Pharmaceuticals (ALNY) - again, CRISPR Therapeutics (CRSP) and AxoGen (AXGN)

Wednesday: Alnylam Pharmaceuticals (ALNY), Vericel (VCEL) and Regenxbio (RGNX)

Tuesday: Ultragenyx (RARE), CRISPR Therapeutics (CRSP), uniQure NV (QURE)

Monday: Blueprint Medicine (BPMC), Ultragenyx (RARE) and Prime Medicine (PRME)

 

While The worst three (3) in the session:

Friday: BioLife Solutions (BLFS), Ionis Pharmaceuticals (IONS) and Verve Therapeutics (VERV)

Thursday: Ultragenyx (RARE), Blueprint Medicine (BPMC) – again and Intellia Therapeutics (NTLA)

Wednesday: Blueprint Medicine (BPMC), CRISPR Therapeutics (CRSP) and Beam Therapeutics (BEAM)

Tuesday: Alnylam Pharmaceuticals (ALNY) – again, Verve Therapeutics (VERV) – again and Beam Therapeutics (BEAM)

Monday: Alnylam Pharmaceuticals (ALNY), CRISPR Therapeutics (CRSP) and Verve Therapeutics (VERV)

 

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 ++ (newest 10-K does NOT REVEAL)

•              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 $5.9 M it took to settle out the executive responsibility as it was SHIFTED to the company shareholders and Harvard Bio (HBIO)???

•              On April 28, 2022, the Company entered into a Preferred Issuance Agreement, or PIA, with Harvard Bioscience, Inc., or HBIO, dated as of April 27, 2022. Pursuant to the PIA, the Company and HBIO agreed that once HBIO had paid at least $4.0 million in certain settlement and related legal expenses, to satisfy the Company’s indemnification obligations with respect thereto, in lieu of paying cash, the Company would issue senior convertible preferred stock to HBIO that will contain terms as described in the PIA. <10-K>

•              On June 10, 2022, following the execution of a subscription agreement and HBIO providing evidence of payment of the requisite $4.0 million amount, the Company issued HBIO 4,000 shares of Series E Convertible Preferred Stock, or Series E Preferred Stock, at a price of $1,000 per share to satisfy the Company’s related indemnification obligations pertaining to the $4.0 million, in lieu of paying cash. <10-K>

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

•              HRGN schedules earnings LPS (loss-per-share) – al but broke as 3–5-year clinical trial begins – four (4) years after IND approved

·         How much of HRGN has been funded by DPhone, the largest cell phone company in China; also, WHAT is its relationship with MSS, the Chinese national security organization??

 

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.