August 24, 2023 4:44pm

As I stated on Monday, “are the upsides at risk by non-investor algorithmic and electronic trading”? Not a guess, I was right!

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.

Pre-Open indications: 3 Hits and 1 Miss

Never leave an investor uninformed! 

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 -373.56 or -1.08%, the S&P closed DOWN -59.70 or -1.35% while the Nasdaq closed DOWN -257.06 points (-1.87%)



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 Thursday as investors looked ahead to a key speech from Fed Chair Powell.

Economic Data Docket: Initial jobless claims last week fell more than expected. First-time filings for unemployment benefits totaled 230,000 for the period ended Aug. 19, a decrease of 10,000 from the previous week and less than the Dow Jones estimate for 240,000. Continuing claims, data for which runs a week behind, totaled 1.702 million, a slight decrease but a bit higher than the FactSet estimate for 1.69 million.

·         Demand for big-ticket items such as appliances, computers and transportation equipment fell more than expected in July, the Commerce Department reported. Durable goods orders slid 5.2% for the month, worse than the 4.1% estimate from Dow Jones, according to a preliminary reading. <CNBC>

·         investors waited for signals on monetary policy from Powell’s comments at the Jackson Hole, Wyoming meeting on Friday.


Thursday (8/24) … RegMed Investors’ (RMi) Opening Bell: “anticipation versus expectation. 4 positives followed by 6 negative closes; think algos and electronic trading will stay involved?” …


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

  • Thursday’s advance/decline line opened negative at 9 up/ 25 down and 2 flats, stayed negative with 7 up/ 26 down and 2 flats at the mid-day, ending with a negative close of 11 incliners, 23 decliners and 1 flat


Pre-Open indications: 3 Hits < Blueprint Medicine (BPMC +$0.01), CRISPR Therapeutics (CRSP -$0.39), Verve Therapeutics (VERV -$0.87)> and 1 Miss < Ionis Pharmaceuticals (IONS +$0.27)>  


Ebb and flow:

  • Q3: August – 6 positive and 12 negative closes


Key Metrics:

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

  • Thursday, the IBB was down -0.91% and the XBI was down -1.38%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Thursday was up +1.11 point or +6.95% at 17.09


Closing Down (10 of 23):

  • Alnylam Pharmaceuticals (ALNY -$3.61 after Wednesday +$1.00 after Tuesday’s +$0.65 and Monday’s +$2.70),
  • Verve Therapeutics (VERV -$0.98 after Wednesday +$0.40 after Tuesday’s -$0.05 after Monday’s -$0.06),
  • CRISPR Therapeutics (CRSP -$0.85 after Wednesday +$1.53 after Tuesday’s +$1.04 and Monday’s -$0.21),
  • Intellia Therapeutics (NTLA -$0.83),
  • Vericel (VCEL -$0.57 after Wednesday +$0.20 after Tuesday’s +$0.40 after Tuesday’s +$0.33 and Monday’s -$0.25),
  • Beam Therapeutics (BEAM -$0.44 after Wednesday +$0.20, Tuesday’s -$0.40 after Monday’s +$0.36),
  • MiMedx (MDXD -$0.33 after Wednesday +$0.20),
  • BioLife Solutions (BLFS -$0.26)
  • uniQure NV (QURE -$0.22 after Wednesday -$0.13),
  • AxoGen (AXGN -$0.20),


Flat (1):

  • Harvard Apparatus RN (HRGN)


Closing Up (11 of 11):

  1. Ultragenyx Pharmaceuticals (RARE +$0.37 after Wednesday’s +$0.52, Tuesday’s -$0.89 and Monday’s +$1.88),
  2. Ionis Pharmaceuticals (IONS +$0.09 after Wednesday’s +$0.40, Tuesday’s +$0.12 and Monday’s -$0.35),
  3. bluebird bio (BLUE +$0.09),
  4. Granite Bio (GRPH +$0.07),
  5. Editas Medicine (EDIT +$0.06 after Wednesday’s -$0.04, Tuesday’s +$0.17 and Monday’s -$0.04),
  6. Bellicum Pharmaceuticals (BLCM +$0.06 after Wednesday’s +$0.2235),
  7. Sage Therapeutics (SAGE +$0.02)
  8. Mesoblast (MESO +$0.02),
  9. Brainstorm Cell Therapeutics (BCLI +$0.02 after Wednesday’s -$0.02)
  10. Homology Medicine (FIXX +$0.01)


Q3/23 – August

  • Thursday closed negative with 11 incliners, 23 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 Dow, S&P and Nasdaq fell ahead of a speech by Fed Chair Jerome Powell.

Reiterating: economic factors effecting share pricing …

·         Earlier Thursday, first-time unemployment claims unexpectedly fell to 230,000 vs. 240,000 in the previous week, Labor Department data showed. Economists had expected them to rise to 241,000.

·         Durable goods orders fell 5.2% in July, more than estimates for a 4% decline. Excluding transportation, durable goods orders rose 0.5%, above forecasts.


It has been a cruel summer for Nasdaq index, which is on pace for its worst Augusts since 2015 and 2001 … markets will be on pins and needles regarding what the Fed will do all through September and into October.


investors are anxious to hear Powell's comments at Jackson Hole. Concerns the Fed will keep interest rates higher for longer have pushed up U.S. Treasury yields, and fanned worries about the impact of higher rates on businesses and consumers.


Cell and gene therapy sector equity dived to the abyss after flitting with the upside on Tuesday after ascending to new heights on Wednesday after “pooping the bed” most of last week and most of the month of august while upbeat economic data kept alive fears of interest rates remaining higher for longer.


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>


What’s Cathy Woods, Ark Invest buying and up to in healthcare and biotech?

ARKK invested in the following healthcare and biotech companies: Ginkgo Bioworks (DNA), Accolade (ACCD), Recursion Pharmaceuticals (RXRX), Crispr Therapeutics (CRSP), Adaptive Biotechnologies (ADPT) and Intellia Therapeutics (NTL). <Motley Fool>


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!”


The top three (3) performing in the session:

Thursday: Ultragenyx Pharmaceuticals (RARE), Editas Medicine (EDIT) and Ionis Pharmaceuticals (IONS)

Wednesday: CRISPR Therapeutics (CRSP) - again, Alnylam Pharmaceuticals (ALNY) – again and Blueprint Medicine (BPMC)

Tuesday: CRISPR Therapeutics (CRSP), Alnylam Pharmaceuticals (ALNY) and Ultragenyx Pharmaceuticals (RARE)

Monday: Alnylam Pharmaceuticals (ALNY), Ultragenyx Pharmaceuticals (RARE) and Blueprint Medicine (BPMC)


While the worst three (3) in the session:

Thursday: Alnylam Pharmaceuticals (ALNY), Verve Therapeutics (VERV) and Vericel (VCEL)

Wednesday: uniQure NV (QURE), Agenus (AGEN) and Editas Medicine (EDIT) 

Tuesday: Blueprint Medicine (BPMC), Ultragenyx Pharmaceuticals (RARE) and Beam Therapeutics (BEAM)

Monday: Vericel (VCEL), Sage Therapeutics (SAGE), Alnylam Pharmaceuticals (ALNY) – again, Graphite Bio (GPPH)  


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, accounting firms and employees have LEFT sine 11/1/13 when it spun out of Harvard Biosciences (HBIO) – guess more to come? Also, how many consultants and CROs were left UNPAID after months of getting IND filed?

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.

·         The Company expects that its operating cash and short-term investments on-hand as of June 30, 2023 of approximately $4.7 million will enable it to fund its operating expenses and capital expenditure requirements into the Q1/2024.

·         Therefore, these conditions present risks about the Company’s ability to continue as a going concern.

·         WHO would INVEST??

·         HRGN will NEED to raise additional funds to fund its operations.

·         In the event the Company is unable to raise additional capital from outside sources before or during the Q1/2024, it may be forced to curtail or cease its operations.

Will HRGN ESCAPE the scandals when its “former” corporate name <Biostage BSTG)> 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 (HBIO) dated as of April 27, 2022. Pursuant to the PIA, the Company and HBIO agreed that once HBIO had paid at least $4 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


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.