August 1, 2022 5:06pm

More frequently right than consequentially wrong

Pre-open indications: 3 HITs and 0 MISS

News: Cellectis (CLLS +$0.38) the U.S. FDA has cleared IND application to initiate a P1/2a clinical trial of UCART20x22 for patients with relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL). BEAM Therapeutics (BEAM -$4.14) the FDA placed a cancer study on hold; BEAM's approach would use donor cells hoping to treat patients with T-cell acute lymphoblastic leukemia.

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?

No tunnel vision here, I get into the weeds of daily share pricing and causes 

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 -46.73 points (-0.14%); the S&P closed DOWN -11.66 points (-0.28%) while the Nasdaq closed DOWN -21.71 points (-0.18%)



Indexes see-sawed then plunged on Monday as world factory data showed demand weakening under inflation pressures, while the looming possibility of recession curbed risk appetite.

All three (3) major U.S. indexes were last modestly lower on August first, coming on the heels of the S&P 500's and the Nasdaq's biggest monthly percentage gains since 2020.

Economic Data Docket: Institute for Supply Management's (ISM) purchasing managers' index (PMI) showed U.S. factory activity decelerated in July to its lowest level since August 2020, but remained in expansion territory and long-running supply restraints appeared to be easing.

·         The report follows a swath of data from Europe and Asia that showed factory activity slowing or contracting in the face of dampened global demand and persistent inflation. <Reuters>


RegMed Investor’s (RMi) Pre-Open: “will August be the month of my portfolio’s discontent? Maybe, I might be proven wrong as earnings season is usually a range breaker.” …


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

  • Monday’s advance/decline line opened positive at 19 up/ 15 down and 1 flat, flipped negative with 10 up/23 and 1 flat at the mid-day, ending with a negative close of 8/26 and 1 flat.


Pre-open Indications: 3 HITs < Biostage (OTCQB: BSTG $0.00 with 8 shares traded); Fate Therapeutics (FATE -$0.49), Ultragenyx (RARE -$2.65)> 0 MISS


Key Metrics:

  • Monday - Sector volume was LOW with 1 of the 8-upside having higher than the 3-month average volume with LOW volume of 4 of 26-downside having higher than the 3-month average volume;

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

  • Monday, the IBB was down -1.46% and the XBI was down -2.05%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +1.51 points or +7.08% at 22.84


Jumping with share pricing momentum (8 of 8):

  • AxoGen (AXGN +$0.43),
  • Cellectis SA (CLLS +$0.38),
  • Brainstorm Cell Therapeutics (BCLI +$0.16 after Friday’s +$0.01),
  • Sage Therapeutics (SAGE +$0.04 after Friday’s -$0.42),
  • BioLife Solutions (BLFS +$0.02),
  • Verastem (VSTM +$0.01),
  • Bellicum Pharmaceuticals (BLCM +$0.01),
  • Solid Biosciences (SLDB -$0.0091),


  • Biostage (BSTG $0.00 after Friday’s $0.00)

Closing down (10 of 26):

  • Beam Therapeutics (BEAM -$4.14 after Friday’s -$2.70),
  • Ultragenyx (RGNX -$2.65 after Friday’s +$1.40),
  • Alnylam Pharmaceuticals (ALNY -$2.09 after Friday’s -$1.48),
  • Verve Therapeutics (VERV -$2.02 after Friday’s -$2.93),
  • Intellia Therapeutics (NTLA -$2.02 after Friday’s -$0.90),
  • uniQure NV (QURE -$1.23 after Friday’s +$0.25),
  • Vericel (VCEL -$1.09 after Friday’s +$0.94),
  • CRISPR Therapeutics (CRSP -$0.99 after Friday’s -$0.90),
  • Fate Therapeutics (FATE -$0.49 after Friday’s -$1.62),
  • Regenxbio (RGNX -$0.33 after Friday’s -$0.96),


August, Q3/2022:

  • Monday closed negative with 8 incliner, 26 decliners and 1 flat


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

As I have been writing … “I am STILL … NOT convinced the lows are in the cell and gene therapy sector.”

Sector expectations are really low in further coming earnings season reporting; remember, a little bit of good news can go a long way when you have low expectations.

Last week post two (2) earnings were a split decision as ALNY reported a net loss as did RARE; yet ALNY dropped Friday -$1.48 or -1.03% and another -$2.09 or -1.47% on Monday after reporting and RARE jumped +$1.40 or +2.70% and crashed Monday -$2.65 or -4.97% following the earnings release.

Volume is still low …

Although, I’m STILL a firm believer in the flight of Icarus …  since the cell and gene therapy equities have oscillated between gains and losses since the first of the year... a bigger “slip” is on the way – maybe NOT today but, it’s coming!

Hold-on (to the railing) as our portfolios weather these volatile sessions as an ordinary practice.

The coming next two (2) weeks will reveal more about the cell and gene therapy sector's state of health.

Next week … the cell and gene therapy sector Q2 earnings continue full-force: Sage Therapeutics (SAGE) on 8/2; and AxoGen (AXGN), Editas Medicine (EDIT), Fate Therapeutics (FATE), MiMedx (MDXG) and Vericel (VCEL) on Wednesday, 8/3, Agenus (AGEN) and Intellia therapeutics (NTLA) and Sangamo Therapeutics (SGMO) on 8/4 followed by Global Blood Therapeutics (GBT) on 8/8 before Ionis Pharmaceuticals (IONS) on 8/9.

investors should be bracing for a milder-than-usual earnings season and downwardly LPS (loss-per-share) predictions,

I find it very interesting to evaluate share price over earnings as a proxy for performance.

We always need a villain and they are multiplying – “Earnings’ season is coming, investors NEED to focus on LPS (loss-per-share), collaboration revenues and cash positions i.e., runways”.

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.