June 10, 2022 5:04pm

News: bluebird bio's (BLUE +0.00%) has scored two endorsements in as many days from an advisory committee to the U.S. FDA advisory committee.  Applied Genetic Technologies (AGTC) received written notice from the Nasdaq indicating that the Company is not in compliance with the $1.00 minimum bid price requirement for continued listing.

Pre-open indications:  1 PUFF/Pump/Promote as Biostage (BSTG) prepares another 5 M share raise

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?

It’s a quick read to understand the ebb and flow of the session in one site

The week in review - what happened and to whom, the root metrics

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 -880 points (-2.73%); the S&P closed DOWN -116.96 points (-2.91%) while the Nasdaq closed DOWN -414.20 points (-3.52%)

 

Henry’omics:

Indexes fell – the Dow -2.26%, the S&P -2.70% and the Nasdaq dived -3.45%) as investors feared the Biden’s administration’s inability to control inflation will be so harsh it will slow growth and over-shadow share pricings.

Inflation has also become a key determinant in the path forward for the Federal Reserve's monetary policies. As the Fed aims to help bring down fast-rising prices, the central bank is widely expected to raise interest rates by another half-point at next week's policy-setting meeting, further increasing the cost of borrowing and doing business for companies. <Yahoo Finance>

The stronger-than-expected CPI data has changed the calculus for what the Fed does in September.

 

News continued: bluebird bio (BLUE)

BLUE's stock was halted on Thursday while the committee discussed and then voted on elivaldogene autotemcel. In a news release, the company said that if the therapy receives FDA approval, it "will be the first and only gene therapy for the treatment of early active CALD." BLUE's stock is also halted on today while the committee discusses the risks and benefits of another gene therapy being developed. BLUE has asked the FDA to approve betibeglogene autotemcel as a treatment for beta thalassemia. BLUE's stock is down- 61.9% this year.

 

RegMed Investors’ (RMi) pre-open: “CPI dominates, rising 8.6% in May, highest since 1981 and worse than feared. The cell and gene therapy sector is showing a lot of worrisome signs – yet again!” … https://www.regmedinvestors.com/articles/12468

 

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

  • Friday opened negative at 2 up/ 31 downs and 2 flats, stayed negative at the mid-day to 2/32 and 1 flat, ending with a negative close of 2/32 and 1 flat <BLUE - halted>.
  • Thursday opened negative at 3 up/ 30 downs and 2 flats, stayed negative at the mid-day to 5/28 and 2 flats, ending with a negative close of 5/28 and 2 flats.
  • Wednesday opened positive at 27 up/7 downs and 1 flat, stayed positive at the mid-day to 20/12 and 3 flats, ending with a positive close of 22/10 and 3 flats.
  • Tuesday opened positive at 26 up/8 downs and 1 flat, stayed positive at the mid-day to 29/4 and 2 flats, ending with a positive close of 30/3 and 2 flat.
  • Monday opened negative at 10 up/25 downs and 3 flats, stayed negative at the mid-day to 5/27 and 3 flats, ending with a negative close of 11/23 and 1 flat (BCLI).

 

Pre-open Indications: < 1 Puff/Pump/Promote < Biostage (BSTG +$0.045 with 295 shares traded)>

 

52-weeek low:

  • Mesoblast (MESO) at $2.76
  • Global Blood Therapeutics (GBT) at $22.36
  • Cellectis SA (CLLS) at $2.82,
  • Caribou Biosciences (CRBU) at $6.34

 

Key Metrics: review the disparities between daily sessions …

  • Friday - Sector volume was LOW with 1 of the 2-upside having higher than the 3-month average volume with LOW volume of 11 of 32-downside having higher than the 3-month average volume;
  • Thursday - Sector volume was LOW with 1 of the 5-upside having higher than the 3-month average volume with LOW volume of 7 of 28-downside having higher than the 3-month average volume;
  • Wednesday - Sector volume was MODERATE with 10 of the 22-upside having higher than the 3-month average volume with LOW volume of 2 of 10-downside having higher than the 3-month average volume;
  • Tuesday - Sector volume was MODERATE with 11 of the 30-upside having higher than the 3-month average volume with HIGHER volume of 2 of 3-downside having higher than the 3-month average volume;
  • Monday - Sector volume was HIGHER with 5 of the 11-upside having higher than the 3-month average volume with MODERATE volume of 12 of 23-downside having higher than the 3-month average volume;

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

  • Friday, the IBB was down -3.07% and the XBI was down -4.60%
  • Thursday, the IBB was down -3.49% and the XBI was down -4.03%
  • Wednesday, the IBB was up +0.25% and the XBI was up +0.81%
  • Tuesday, the IBB was up +2.25% and the XBI was up +5.04%
  • Monday, the IBB was down -1.08% and the XBI was down -2.85%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Friday was up +1.79 points or +6.86% at 27.88
  • Thursday was up +2.25 points or +9.39% at 26.21
  • Wednesday was up +0.02 points or +0.08% at 24.04
  • Tuesday was down -1.08 points or -4.31% at 23.99
  • Monday was up +0.25 points or +1.01% at 25.04

 

Jumping with share pricing momentum (2 of 2):

  • Biostage (BSTG +$0.06, after Thursday’s $0.00, Wednesday’s $0.00, Tuesday’s $0.00 and Monday’s +$0.23),
  • Brainstorm Cell Therapeutics (BCLI -$0.02),

Closing down (10 of 32):

  • Ultragenyx (RARE -$1.21 after Thursday’s -$3.30 after Wednesday’s +$1.16, Tuesday’s +$3.97 and Monday’s -$2.15),
  • uniQure NV (QURE -$1.23),
  • Verve Therapeutics (VERV -$1.43 after Thursday’s -$0.96, Wednesday’s +$0.28 and Tuesday’s +$1.18)
  • Caribou Biosciences (CRBU -$1.78),
  • Alnylam Pharmaceuticals (ALNY -$3.17 after Thursday’s -$4.40, Wednesday’s +$5.39, Tuesday’s +$2.38 and Monday’s +$0.11),
  • Sage Therapeutics (SAGE -$2.81),
  • Fate Therapeutics (FATE -$3.73, After Thursday’s -$0.78, Wednesday’s -$0.03, Tuesday’s +$2.29 and Monday’s -$1.65),
  • Beam Therapeutics (BEAM -$4.68 after Thursday’s -$2.39, Wednesday’s +$1.66, Tuesday’s +$2.63 and Monday’s -$1.39),
  • Intellia Therapeutics (NTLA -$7.69 after Thursday’s -$1.86, Wednesday’s +$3.90 and Tuesday’s +$2.91),
  • CRISPR Therapeutics (CRSP-$8.18 after Thursday’s -$2.13, Wednesday’s +$4.79, Tuesday’s +$4.82 and Monday’s +$0.01),

Flat:

  • bluebird bio (BLUE) – halted Thursday

 

June, Q2/2022:

  • Friday closed negative with 2 incliner, 32 decliners and 1 flat
  • Thursday closed negative with 5 incliner, 28 decliners and 2 flats
  • Wednesday closed positive with 22 incliner, 10 decliners and 3 flats
  • Tuesday closed positive with 30 incliner, 3 decliners and 2 flats
  • Monday closed negative with 11 incliner, 23 decliners and 1 flat

 

The BOTTOM LINE:  A SAD session for our universe, market and economy!

Yesterday, I stated there’s a lot of head fakes going on.

We always need a villain – Inflation affecting markets with downslides has remained a dominant issue for investors.

The consumer price index inflation “numbers” as to the CPI accelerating 8.6% year-over-year (YOY) following April's 8.3% rise. That marked the biggest jump since late 1981, and took out the prior 41-year high set in the March CPI, which rose 8.5%.

We NEED to understand the “numbers” … on a month-over-month basis, CPI also jumped by 1.0%, or more than the 0.7% rise expected, and April's 0.3% increase. Core inflation, which excludes volatile food and energy prices, increased 6.0% on an annual basis after April's 6.2% increase.

Which investors will be BUYING equities if we can barely afford gas (+50%) and food (+10%)!

I try to keep it simple and short … because there’s so much worry that people use any piece of good news as a chance to sell – it has become a process of developing ROI (return of investment).”

Reiterating, I believe there will be opportunity in cell and gene therapy equities but, the summer doldrums are still a roadblock. This period of volatility will likely last into the second half of the year.

What changes … NOTHING …  it’s a CONSTANT tug-of-war!

However, the continuing state of volatility confirms fears that I have been expressing these daily and weekly posts.

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.