September 26, 2023 4:41pm

As indexes crashed, the cell and gene therapy sector responded to “uncle algo and his electronic trading dwarfs” visit but, how long will it last – one (1) to three (3) sessions i.e., month and Q3’s end?

News: MiMedx Group (MDXG +$0.07) launched EPIEFFECT™ treating acute and chronic, hard-to-heal wounds such as diabetic foot ulcers (“DFUs”) and venous leg ulcers (“VLUs”),

Pre-open Indications: 1 Hit and 5 Miss

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Investors crave share pricing explanations because they give us an illusion of portfolio control. I know what a company is supposed to look like, be like, and smell like to succeed; bottom line, investors own the right to exit or enter sector’s share pricing.

 

The Dow closed DOWN -388.13 points or -1.14%, the S&P closed DOWN -63.91 points or -1.47% while the Nasdaq closed DOWN -207.71 points or -1.57

 

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 after the latest home sales and consumer confidence reports stoked concern over the state of the U.S. economy.

Economic Data Docket: new home sales in August fell short of expectations while consumer confidence by one measure also was lower than expected.

·         Case-Shiller index showed 20-City composite prices rise just 0.1% from a year ago in July, compared to the 1.2% decline in June. That increase was less than the 0.3%.

·         The Conference Board’s consumer confidence index declined to 103 for September, down from 108.7 in August and below the 105.5 estimate. Importantly, the expectations index tumbled to 73.7, below the 83.3 in August and less than the 80 reading generally associated with recessions.

·         The Richmond Fed’s manufacturing index rose to 5 for September, up from -7 in August and better than the -5.5 estimate.

 

52-week low:

Solid Biosciences (SLDB) at $2.57

Sangamo Therapeutics (SGMO) at $0.67

Prime Medicine (PRMC) at $10.25

 

Tuesday (9/26) … RegMed Investors’ (RMi) Opening Bell: “it's always darkest before the dawn. The cell and gene therapy sector lately seems to get worse before it gets better - even in the worst of circumstances there is hope although Monday’s aftermarket was very weak.” … https://www.regmedinvestors.com/articles/13136

 

Pre-Open indications: 1 Hit < Ionis Pharmaceuticals (IONS +$3.62)> and 5 Miss < Ultragenyx Pharmaceuticals (RARE +$0.74), Alnylam Pharmaceuticals (ALNY +$4.28), Verve Therapeutics (VERV +$1.57), Prime Medicine (PRME -$0.32), Editas Medicine (EDIT -$0.05)>

 

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

  • Tuesday’s advance/decline line opened positive at 27 up/ 7 down and 1 flat, stayed positive at the mid-day with 22 up/ 12 down and 1 flat, ending with a positive close of 22 incliners, 12 decliners and 1 flat

 

Ebb and flow:

Q3: September – 1 holiday, 7 positive and 10 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:

  • Tuesday, the IBB was up +0.35% and the XBI was up +1.86%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was up +2.43 points or +14.38% at 19.33

 

Closing Down (12 of 12):

  • Vericel (VCEL -$0.50 after Monday’s $0.00),
  • Prime Medicine (PRMC -$0.32 after Monday’s -$0.51),
  • AxoGen (AXGN -$0.31 after Monday’s +$0.14),
  • Solid Biosciences (SLDB -$0.15),
  • Bellicum Pharmaceuticals (BLCM -$0.13),
  • Graphite Bio (GRPH -$0.08 after Monday’s +$0.18)
  • Fate Therapeutics (FATE -$0.06),
  • Caribou Therapeutics (CRBU -$0.05),
  • Editas Medicine (EDIT -$0.05 after Monday’s -$0.74),
  • Brainstorm Cell Therapeutics (BCLI -$0.03 after Monday’s -$0.38),
  • Compass Therapeutics (CMPX -$0.03 after Monday’s +$0.06),
  • Sangamo Therapeutics (SGMO -$0.0165)

FLAT (1)

  • Harvard Apparatus RN (HRGN $0.00 after Monday's -$0.39 and Friday’s $0.00),

Closing Up (10 of 22):

  • Alnylam Pharmaceuticals (ALNY +$4.28 after Monday’s -$0.78),
  • Ionis Pharmaceuticals (IONS +$3.62),
  • Sage Therapeutics (SAGE +$1.58 after Monday’s -$0.30),
  • Verve Therapeutics (VERV +$1.57 after Monday’s -$0.67),
  • Ultragenyx Pharmaceuticals (RARE +$0.74 after Monday’s +$0.24),
  • Blueprint Medicine (BPMC +$0.60),
  • Beam Therapeutics (BEAM +$0.59 after Monday’s -$0.75),
  • BioLife Solutions (BLFS +$0.42 after Monday’s +$0.15),
  • Regenxbio (RGNX +$0.29 after Monday’s -$0.23),
  • CRISPR Therapeutics (CRSP +$0.25 after Monday’s +$0.37)

 

Q3/23 – September

  • Tuesday closed positive with 22 incliners, 12 decliners and 1 flat
  • Monday closed negative with 7 incliners, 26 decliners and 2 flats

 

The BOTTOM LINE: I try to keep it simple … and short!

Key word of the state of uncertainty in “our” universe of cell and gene therapy … “which makes It difficult to predict where sector is headed in the short run.”

Invest like you're driving on an icy, windy road, not an open highway. Proceed carefully, or wait it out on the side of the road.

 

Contributing to today’s (9/26) updraft:

  • Post 7 down sessions, it was deemed to happen
  • Traders, algorithms and electronic trading

 

The cell and gene therapy sector equities share pricing “popped” on Tuesday after Monday dived following Friday, Thursday, Wednesday, Tuesday and last Monday’s negativity.

 

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!”

 

Some bad news:

Morphic Therapeutics (MORF) <Waltham, Mass> stock nosedived Friday -36.9% Monday -25% to $23.19 and Tuesday -$1.20 or -5.19% as ulcerative colitis drug underperformed a rival from Takeda Pharmaceutical (TAK) and on disappointing trial data.

MORF has had a rough couple of years now with two Big Pharma’s abandoning partnerships and its only clinical-stage drug posting less-than-encouraging data.

After 12 weeks of treatment, 25.7% of patients who received the Morphic drug showed endoscopic improvement. But that pales in comparison with the 41% endoscopic improvement shown by Takeda's Entyvio, RBC Capital Markets analyst Gregory Renza said in a note to clients.

 

Still waiting on today’s meeting:

Cellular Therapy and Gene Therapies Advisory Committee meeting will meet in open session to discuss for NurOwn® and make recommendations on Brainstorm Cell Therapeutics (BCLI) biologics license application (BLA) for debamestrocel (autologous bone marrow-derived MSC cell therapy) for the treatment of amyotrophic lateral sclerosis (ALS).

 

The top three (3) performing in the session:

Tuesday: Alnylam Pharmaceuticals (ALNY), Ionis Pharmaceuticals (IONS) and Sage Therapeutics (SAGE)

Monday: CRISPR therapeutics (CRSP), Ultragenyx Pharmaceuticals (RARE) and Graphite Bio (GRPH)

The worst three (3) in the session:

Tuesday: Vericel (VCEL), AxoGen (AXGN) and Prime Medicine (PRME)

Monday: Alnylam Pharmaceuticals (ALNY) – 8x, Beam Therapeutics (BEAM) – 2x and Editas Medicine (EDIT)

 

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.

 

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

·         WHY does Chinese investor DST Capital and Beijing based Dixintong Technology Group need a regenerative medicine/biotech public and money losing company in its investment group that resides in the middle of medical and scientific innovation in America?

·         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.

·         Question #1, did you notice how it barely trades unless volume is “pump” – is it by DST Capital, 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??

·         Questions #2, 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, the largest cell phone company in China), Ting Li (Donghai Securities Co., Ltd) - all reside in China – what are their affiliations with China’s security service - MSS??

·         Monday, 9/25 – HRGN was flat after Monday’s declines -$0.39 <down from -$1.36> with 1,289 shares traded after last week’s closes – Friday’s $0.00 after Thursday’s $0.00, Wednesday’s $0.00 and last Tuesday’s -$0.09 and the previous Monday’s $0.00.

 

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.