August 30, 2023 4:45pm

Daedalus and Icarus flew using wings made of wax and feathers. Ignoring his father’s warnings, Icarus flew too close to the sun and met a tragic end.

Pre-open Indications: 5 Hits and 1 Miss <a portfolio was strengthened and a buck was generated>

Subscription is coming, it is not conscription but, an offer to join our collective of like-minded investors!  Join me … in the NO spin zone.

Never leave an investor uninformed! 

If I have learned one thing as a former research analyst in a venture and public fund, multiple operating roles, 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 +37.57 or +0.11%, the S&P closed UP +17.24 or +0.38% while the Nasdaq closed UP +75.55 points or +0.54%



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 up/positive even as investors assessed new U.S. economic data.

Wednesday’s moves come as traders’ pore over disappointing payrolls data.

Economic Data Docket: ADP said private employers added 177,000 jobs in August. That is well below a revised July number of 371,000. It also missed a Dow Jones estimate of 200,000.

·         Annual gross domestic product growth was downwardly revised on Wednesday to 2.1% from the previous 2.4% forecast which is a slight downward revision from the preliminary 2.4% estimate. 

·         Other revisions also include personal consumption, which ticked up slightly to 1.7%.

·         Pending home sales in July fell sharply from a year ago, the latest in a line of economic reports that suggests a slowing economy.


Wednesday (8/30) … RegMed Investors’ (RMi) Opening Bell: “the Icarus metaphor. The sector flew high, has it overreached its limits and will algorithms and electronic trading let the sector’s share pricing keep its wings/pricing?”  …


Pre-Open indications: 5 Hits < AxoGen (AXGN -$0.25), CRISPR Therapeutics (CRSP -$0.05), Ionis Pharmaceuticals (IONS -$0.49), Generation Bio (GBIO -$0.33), Vericel (VCEL +0.28)> 1 Miss < Alnylam Pharmaceuticals (ALNY +$2.70) >


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 14 up/ 19 down and 2 flats, stayed negative with 13 up/ 21 down and 1 flat at the mid-day, ending with a negative close of 12 incliners, 22 decliners and 1 flat


Ebb and flow:

  • Q3: August – 9 positive and 13 negative closes


Key Metrics:

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

  • Wednesday, the IBB was up +0.29% and the XBI was up +0.50%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Wednesday was down -0.58 point or -4.01% at 13.87


Closing Down (10 of 22):

  • Ionis Pharmaceuticals (IONS -$0.49 after Tuesday’s +$0.20 and Monday’s +$0.54),
  • Generation Bio (GBIO -$0.33),
  • AxoGen (AXGN -$0.25 after Tuesday’s +$0.25),
  • uniQure NV (QURE -$0.24),
  • Intellia Therapeutics (NTLA -$0.23),
  • Beam Therapeutics (BEAM -$0.21 after Tuesday’s +$0.29 and Monday’s +$0.22),
  • Prime Medicine (PRMC -$0.16 after Tuesday’s +$0.20 and Monday’s +$0.36),
  • Sage Therapeutics (SAGE -$0.14 and Tuesday’s -$0.08),
  • Harvard Apparatus RM (HRGN -$0.10 after Tuesday’s +$0.21 and Monday’s +$0.27),
  • Bellicum Pharmaceuticals (BLCM -$0.09 after Tuesday’s -$0.019 and Monday’s -$0.045)

Flat (1);

  • Homology Medicine (FIXX)

Closing Up (12 of 12):

  • Alnylam Pharmaceuticals (ALNY +$2.70 after Tuesday’s +$2.80 and Monday’s +$2.40),
  • Blueprint Medicine (BPMC +$0.45 after Tuesday’s -$0.18 after Monday’s -$1.54),
  • BioLife Solutions (BLFS +$0.34 after Tuesday’s +$1.54),
  • Verve Therapeutics (VERV +$0.30 after Tuesday’s -$0.17 after Monday’s -$0.05),
  • Vericel (VCEL +$0.28 after Tuesday’s +$0.22 and Monday’s -$0.42),
  • Cellectis SA (CLLS +$0.195),
  • Voyager Therapeutics (VYGR +$0.17),
  • Agenus (AGEN -$0.05),
  • MiMedx (MDXG +$0.04 after Tuesday’s -$0.01 after Monday’s -$0.07)
  • Regenxbio (RGNX -$0.03 after Tuesday’s +$0.02 and Monday’s +$0.26),
  • Sangamo Therapeutics (SGMO +$0.028),
  • Precigen (PGEN +$0.01)


Q3/23 – August

  • Wednesday closed negative with 12 incliners, 22 decliners and 1 flat
  • Tuesday closed positive with 20 incliners, 14 decliners and 1 flat
  • Monday closed positive with 24 incliners, 11 decliners and 0 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.”

At ANY time, this week, be ready to take partial profits and exit losers after the cell and gene therapy sector equity after Wednesday’s negative close loss post ascending Tuesday but, with some slippage toward the close after Monday,

·         Last Friday’s positive closes following Thursday’s negative close and past positive closes of the previous Wednesday, Tuesday, Monday. 


As I have stated, “What goes up with ceremony, goes down with disdain followed by the opposite effect.”

And I have also stated, attention remains laser-focused on weeks and end of month’s busy economic calendar; I believe there will be some hesitation side by side with inflation data to really see the reality of the markets and cell and gene therapy sector ability or capacity to continue moving upward.


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 …


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!”


Being “greedy when others are fearful” is easier said than done

When a cell and gene therapy sector equity sells-off to or below a buy point, investors face a tough decision: hold tight, exit or trim the position. There's not necessarily a "right" answer. Sometimes the stock will bounce right back, others will keep falling — perhaps after briefly bouncing. A more-cautious approach may make more sense in the current volatile market.


The top three (3) performing in the session:

Wednesday: Alnylam Pharmaceuticals (ALNY) – 3x again, Blueprint Medicine (BPMC) and BioLife Solutions (BLFS) - again

Tuesday: Alnylam Pharmaceuticals (ALNY) – yet again, BioLife Solutions (BLFS) and CRISPR Therapeutics (CRSP)

Monday: Alnylam Pharmaceuticals (ALNY) – again, Ionis Pharmaceuticals (IONS) and Generation Bio (GBIO)

While The worst three (3) in the session:

Wednesday: Ionis Pharmaceuticals (IONS), Generation Bio (GBIO) and AxoGen (AXGN)

Tuesday: Blueprint Medicine (BPMC), Verve Therapeutics (VERV) and Caribou Biosciences (CRBU)

Monday: Ultragenyx Pharmaceuticals (RARE), Blueprint Medicine (BPMC) and Vericel (VCEL)


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 according to the 8-K and 10-K!

•              Accumulated deficit:  $88.5 M (newest 10-K)

Question: How many CEOs, presidents, VPs, CFOs, CMOs, board members and audit members have … left or been laid-off, accounting firm’s resignations and employees have resigned since 11/1/13 when it spun out of Harvard Biosciences (HBIO) – guess? Also, how many consultants and CROs were left UNPAID after months and years of facilitating IND filed? Answers coming …

Going Concern

·         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.

·         HRGN will NEED to raise additional funds to fund its operations. WHO and WHICH U.S. investors would INVEST with their history??


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.