April 24, 2023 4:51pm

Investor shift focus to Q1 earnings season with LPS (loss-per-share) and runway status.

News: bluebird bio (BLUE +$0.01) submitted its Biologics License Application (BLA) to the U.S. FDA for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events (VOEs). The BLA includes a request for Priority Review, which, if granted, would shorten the FDA’s review of the application to six months from the time of filing, versus a standard review timeline of 10 months.

Pre-open Indications: 4 Hits and 3 Miss

I write this blog/newsletter to inform investors with facts and supporting numbers focused on what they need to hear that others will not say or write about - truth!  

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.

If I have learned one thing as a former research analyst in a venture and public fund, operating executive, adjunct (MBA) business school professor now a journalist; it is that your life and your portfolio are largely tied to your knowledge of price movements and questioning pricing targets.

 

The Dow closed UP +66.44 points (+0.20%), the S&P closed UP +3.52 points (+0.09%) while the Nasdaq closed DOWN -35.25 points (-0.29%)

 

Henry’omics:

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.

Two (2) indexes were up (Dow and S&P) while the Nasdaq dived.

Economic Data Docket: Early readings of first-quarter U.S. GDP, personal consumer expenditure index (PCE) for March, consumer confidence numbers for April are among the data scheduled for release this week.

  • Most Fed policymakers over the past week acknowledged the central bank has more work to do on bringing down inflation, before entering the blackout period until the next policy meeting. <Reuters>

 

Monday (4/24) … RegMed Investors’ (RMi) pre-open: “the push-pull of April’s share pricing facilitates more uncertainty in the short-term. Q1/23 earnings release this week: Sangamo Therapeutics (SGMO) reports Wednesday – 4/26.” …  https://www.regmedinvestors.com/articles/12928

 

Pre-open Indications: 4 Hits <Beam Therapeutics (BEAM -$0.65), CRISPR Therapeutics (CRSP -$0.93), BioLife Solutions (BLFS -$0.37), Sage Therapeutics (SAGE -$0.27)> and 3 Miss <Avrobio (AVRO -$0.0443), AxoGen (AXGN -$0.14), Ultragenyx (RARE +$1.37)

 

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

  • Monday’s advance/decline line opened negative at 10 up/ 28 down and 3 flats, stayed negative with 6 up/ 26 down and 3 flats at the mid-day, ending with a negative close of 10/22 and 3 flat
  • Friday’s advance/decline line opened positive at 19 up/ 13 down and 3 flats, stayed positive with 26 up/ 7 down and 2 flats at the mid-day, ending with a positive close of 25/8 and 2 flats

 

Key Metrics:

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

  • Monday, the IBB was down -0.31% and the XBI was down -1.28%
  • Friday, the IBB was up +1.15% and the XBI was up +2.07%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +0.03 points or +0.18% at 16.80
  • Friday was down -0.54 points or -3.15% at 16.63

 

Closing Down (10 of 22):

  • Alnylam Pharmaceuticals (ALNY -$4.49 after Friday’s +$6.42),
  • Ionis Therapeutics (IONS -$1.21 after Friday’s +$0.80),
  • CRISPR Therapeutics (CRSP -$0.93 after Friday’s +$2.12),
  • Verve Therapeutics (VERV -$0.87 after Friday’s +$1.05),
  • Beam Therapeutics (BEAM -$0.65 after Friday’s +$1.07),
  • Intellia Therapeutics (NTLA -$0.63 after Friday’s +$1.38),
  • Vericel (VCEL -$0.61),
  • BioLife Solutions (BLFS -$0.37 after Friday’s +$0.50),
  • Editas Medicine (EDIT -$0.31 after Friday’s +$0.53)
  • Prime Medicine (PRME -$0.28 after Friday’s -$0.02),

Flat (3):

  • Brainstorm Cell Therapeutics (BCLI)
  • Compass therapeutics (CMPX)
  • Mesoblast (MESO)

Closing Up (10 of 10):

  • Ultragenyx (RARE +$1.37 after Friday’s +$0.98),
  • Chinook therapeutics (KDNY +$0.20),
  • Fate Therapeutics (FATE +$0.12),
  • Regenxbio (RGNX +$0.09),
  • Cellectis SA (CLLS +$0.03 after Friday’s -$0.02),
  • MiMedx (MDXG +$0.02),
  • Verastem (VSTM +$0.013 after Friday’s -$0.028),
  • Homology Medicine (FIXX +$0.01 after Friday’s -$0.0184),
  • bluebird bio (BLUE +$0.01),
  • Bellicum Pharmaceuticals (BLCM +$0.005 after Friday’s -$0.05),

 

Q2/23 – April

  • Monday closed negative with 10 incliner, 22 decliners and 3 flats

 

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.”

More frequently right than consequentially wrong …

Too many factors are calling the ball on share pricing – sentiment, economics, earnings, and I believe the political aspect of the country’s leanings, polarization, and disparities of the debt ceilings arguments.

The cell and gene therapy sector is Up, responding to the oversold sirens – after sentiment and conviction slips during the week and the alternating month closes.

Is it time to BUY – NO; wait for after earnings releases and runway (cash positions) “alignment.”

Investors NEED to be hesitant in adding to positions re concerns of upcoming LPS (loss-per-share) metrics.

WHY (?) do I keep posting, so investors can get a daily update of the sector's share pricing and some individual companies TRUTHS while electronic trading chews on our portfolio edges.

Remember, there are four (4) phases of the stock cycle: accumulation; markup; distribution; and markdown.

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!

De-Listing Update: Avrobio (AVRO) Monday closed down -$0.0443 after Friday closed up +$0.08 to $0.95 after Thursday’s -$0.06, Wednesday +$0.026, Tuesday -$0.0245, Monday’s -$0.013 to $0.93, last Friday’s -$0.012, the previous Thursday’s +$0.07, Wednesday’s -$0.06 and Tuesday’s +$0.04 – still under Nasdaq rule of $1.00; after fifteen (15) sessions under the Nasdaq minimum?

·         Doesn’t seem that CEO Geoff MacKay can garner support to forestall de-listing for the second time in months?

·         When is the Nasdaq letter due or has it come and NOT been disseminated to investors?

·         Yet another coverup?
 

Biostage (OTCQB: BSTG) …

Monday closed down -$0.07 with 600 shares traded after Friday closed FLAT with 150 shares traded after Thursday closed down -$0.08 with 150 shares traded after Wednesday closed down -$0.05 with 100 shares traded, Tuesday closed flat with zero shares traded, Monday’s down of -$0.20 with 3,500 shares traded, Friday +$0.25 with 929 shares traded and last Thursday +$0.10 with 150 shares traded, <3-month average =1,757 shares>

·         Did FINANCING happen with US investors – NO mention, possibly ALL … Beijing, China money? What analysts are following the company? - NONE

·         Question: Review the number of shares traded … is OTCQB: BSTG a Ponzi scheme (with their pump/promote buy and sell agenda) as shares are bought to replace those sold??

·         Notice the new director, Ron Packard, MATCH his background to the new Chairman and CEO – education buddies (different companies each in ed field – independent director?

·         Biggest issue – RELIANCE on Chinese off-shore investment as US investors AVOID this equity – wonder WHY?

 

My question that resounds, that should be asked is how many companies are at the end of sentiments …  leash?

 

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.