August 30, 2022 5:23pm

Fear and expectation of September inhibits this market

News: Sangamo Therapeutics (SGMO +$0.08) updated prelim results from the P1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920 for the treatment of Fabry disease. These latest data show that, as of the February 14, 2022 cutoff date, the investigational treatment continued to be generally well tolerated, with no treatment-related adverse events above Grade 1 (mild). The five longest treated patients continued to exhibit elevated alpha-galactosidase A (α-Gal A) activity, sustained up to 15 months as of the last date of measurement. The sixth patient exhibited elevated α-Gal A activity to within normal range at two weeks post dosing.

Pre-open indications: 3 HITs, 4 MISS and 1 Pump/Promote

WHY and HOW is this market affecting the cell and gene therapy sector … “The Bottom Line” underlines the framework of share pricing actions.  Who else is tracking a broad grouping of cell and gene therapy equities – can you afford to not read facts supported by real numbers?

If I have learned one thing as a former research analyst, venture and public fund investor now a journalist; it is that your life and your bank account are largely tied to your knowledge of price movements and questioning pricing targets.


The Dow closed DOWN -308.12 points (-0.96%); the S&P closed DOWN -44.45 points (-1.10%) while the Nasdaq closed DOWN -134.53 points (-1.12%)



The Dow, Nasdaq and the S&P 500 fell slightly below the 50-day line, as the market continues to price in an era of continued high interest rates.

“Investors should expect the market regime of high volatility and range-bound trading to persist for a while longer.” <Reuters>

Economic Data Docket: August’s nonfarm payrolls report on Friday


RegMed Investor’s (RMi) Pre-Open: “time for some bounce, although algos are still hungry. Investors need to come to terms of the cell and gene therapy sector’s state of affairs and health as individual company’s actions cast doubt toward sentiment.” …


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

  • Tuesday’s advance/decline line opened positive at 26 up/ 8 down and 1flat, dived negative with 10 up/25 down at the mid-day, ending with a negative close of 11/22 and 2 flats.


Pre-open Indications: 3 HITs <Chinook Therapeutics (KDNY -$0.87), Sage Therapeutics (SAGE -$1.24), Intellia Therapeutics (NTLA +$1.18)> 4 MISS < Sangamo Therapeutics (SGMO +$0.08), Beam Therapeutics (BEAM -$0.66), CRISPR Therapeutics (CRSP -$0.60), Ionis Pharmaceuticals (IONS -$0.17)> 1 Pump/Promote < Biostage (BSTG +$1.05 with 675 shares traded)>  


Key Metrics: low volume pervades …

  • Tuesday - Sector volume was LOW with 1 of the 11-upside having higher than the 3-month average volume with LOW volume of 1 of 22-downside having higher than the 3-month average volume

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

  • Tuesday, the IBB was down -0.79% and the XBI was down -1.02%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was N/A points or N/A% at 26.21


Jumping with share pricing momentum (11 of 11):

  • Intellia Therapeutics (NTLA +$1.18 after Monday’s +$0.31),
  • Biostage (BSTG +$1.05 after Monday’s -$1.34 after Friday’s +$0.15),
  • Alnylam Pharmaceuticals (ALNY +$0.94 after Monday’s -$1.91),
  • BioLife Solutions (BLFS +$0.52),
  • AxoGen (AXGN +$0.38 after Monday’s -$0.33),
  • Editas Medicine (EDIT +$0.24 after Monday’s +$0.05),
  • Global Blood Therapeutics (GBT +$0.21 after Monday’s +$0.34),
  • Adverum Biotechnologies (ADVM +$0.09),
  • Sangamo Therapeutics (SGMO +$0.08),
  • Verve Therapeutics (VERV +$0.02),
  • Ultragenyx (RARE +$0.01),

Flat (2):

  • Brainstorm Cell Therapeutics (BCLI) and Agenus (AGEN)  

Closing down (10 of 22):

  • Sage Therapeutics (SAGE -$1.24 after Monday’s +$0.37),
  • Fate Therapeutics (FATE -$0.96 after Monday’s -$0.59),
  • Chinook Therapeutics (KDNY -$0.87 after Monday’s +$0.33),
  • Beam Therapeutics (BEAM -$0.66),
  • Regenxbio (RGNX -$0.60 after Monday’s -$0.71),
  • CRISPR Therapeutics (CRSP -$0.60 after Monday’s -$1.60),
  • Vericel (VCEL -$0.48 after Monday’s -$0.73),
  • Caribou Biosciences (CRBU -$0.43),
  • Homology Medicine (FIXX -$0.33),
  • UniQure NV (QURE -$0.27),


August, Q3/2022:

  • Tuesday closed negative with 11 incliner, 22 decliners and 2 flats
  • Monday closed negative with 7 incliner, 27 decliners and 1 flat


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

Cell and gene therapy stocks sank lower to start the week, extending a sell-off that began Friday.

The most significant risk to stocks is weakness in earnings. As a result, equity investors should be laser focused on this risk.

The earnings season is nearing an end; Applied Genetic Technologies (AGTC) has NOT released. The tale end as it ends its fiscal year after a lousy offering and an award of $185 bonus to its CEO after a depreciating share pricing year and it wasn’t the first, second or even third year!

As I have further questioned, “The real question that should be asked is how many companies are at the end of sentiments leash? Start by looking at cell and gene therapy companies trading below cash!” 

Reiterating from this a.m.’s post, Investors need to come to terms of the cell and gene therapy sector’s state of affairs and health as individual company’s actions cast doubts upon sentiment as reflected by two (2) negative sessions, followed by three (3) positive sessions and five (5) negative sessions

Companies NEED transparency and advantage of good practices in relation to outreach to investors which means … NOT to enrich themselves at shareholder’s expense!

CEO salaries, spending the G&A are totally OUT-OF-WHACK; these are companies are in the development stage and will be for years without products in most cases not like the tech companies, who CEOs and management teams think they should be compared to for bi-weekly cash and “beanies”!

When it comes time to invest or even hold onto an investment; I’d say … focus on what percentage ownership of stock … NOT options CEOs and management teams own versus their salary and bonus.

Also, investors can’t afford the outsized valuation price targets by I-Banks research and believe that CEOs are “accomplices” to over-estimating expectation and guidance in regard to valuation

As I have “noticed” yet again from to date reporting, “Most reporting sector companies … to date have reported net losses, lagging revenue estimates … although AXGN, FATE, RGNX, FIXX and NTLA beat on revenues generating forward motion while ATM use is up.”

I find it very interesting to evaluate share price over earnings and a shortage of revenue reporting as a proxy for share pricing performance?

I stick to my view of anticipating the risks – as my careers focus has been “warning analysis”.


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.