March 2, 2023 4:46pm

Pre-open indication Results: 6 Hits and 2 Miss

News: The FDA cleared Intellia Therapeutics (NTLA +$3.24 or +7.95%) the FDA has cleared NTLA’s IND application for NTLA-2002 for the treatment of hereditary angioedema (HAE), enabling a global P2 portion of its ongoing P1/2 study. NTLA-2002 is an in vivo genome editing candidate designed to inactivate the target gene, kallikrein B1 (KLKB1), to permanently reduce plasma kallikrein protein activity and thus prevent HAE attacks after a single-dose treatment.

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

Subscription is coming, it’s 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 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 +341.73 points (+1.05%); the S&P closed UP +29.96 points (+0.76%) while the Nasdaq closed UP +83.50 points (+0.73%)

 

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 …

Indexes flipped to the upside after a fluctuating session.

An informative quote, “The market’s reacting to stronger economic data, and data that is not confirming the correction in inflation,” said Gibson Smith, chief investment officer at Smith Capital Investors. “It’s glaringly clear for equities that we could be an environment where growth is not coming in as high as we would like, and inflation is not coming down as fast as we would like, so the higher rates are starting to split the equity market.”

Economic Data Docket: A surge in labor costs and a pullback in jobless claims were pointing to the likelihood that the Fed will raise its benchmark interest rate another 0.25 percentage point later this month.

·         jobless claims fell to 190,000 for the week ended Feb. 18, down 2,000 from the previous period and below the estimate for 195,000. Continuing claims fell to 1.655 million, down 5,000.

·         Unit labor costs jumped 3.2% for the October to December period, the Labor Department reported Thursday. That was well above the Dow Jones estimate for a 1.6% increase.

·         The increase came from a 4.9% rise in hourly compensation, minus the 1.7% increase in productivity, which was below the 2.5% estimate.

 

News (continued); NTLA begin testing its CRISPR gene-editing technology in people, leading NTLA stock to jump. This is a first for a so-called in-vivo gene-editing drug. NTLA plans to use it to prevent swelling attacks in people with a genetic condition called hereditary angioedema. The treatment is also systemic, meaning a doctor infuses it into a patient's arm. From there, the gene-editing instructions must find their way to the proper organ. In this case, that's the liver.

 

Pre-open indication Results: 6 Hits < Beam Therapeutics (BEAM +$0.31), CRISPR Therapeutics (CRSP +$1.47), Intellia Therapeutics (NTLA) +$3.24), Verve Therapeutics (VERV +$1.97), Chinook Therapeutics (KDNY -$0.14), Caribou Biosciences (CRBU -$0.11)> and 2 Miss < uniQure NV (QURE +$0.08), Prime Medicine (PRME -$0.43)>

 

RegMed Investors (RMi) Research Note: Q4 and FY22 earnings reporting … https://www.regmedinvestors.com/articles/12843

RegMed Investors (RMi) Research Note: Upcoming Q4 earnings reporting dates … https://www.regmedinvestors.com/articles/12830

 

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 13 up/ 19 down and 3 flats, stayed negative with 7 up/ 26 down and 2 flats at the mid-day, ending with a negative close of 12/19 and 4 flats

 

Key Metrics:

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

Thursday, the IBB was up +0.23% and the XBI was down -0.77%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Thursday was down -1 points or -4.86% at 19.58

 

Closing Down (10 of 19):

  • Alnylam Pharmaceuticals (ALNY -$0.96 after Wednesday’s +$3.95 after Tuesday’s +$1.44 and Monday’s +$0.23),
  • Ultragenyx (RARE -$0.60 after Wednesday’s +$1.16 after Tuesday’s +$1.03 and Monday’s +$0.66),
  • Regenxbio (RGNX -$0.60 after Wednesday’s +$1.89 after Tuesday’s +$0.31 and Monday’s +$0.63)
  • Prime Medicine (PRME -$0.43),
  • MiMedx (MDXG -$0.275 after Wednesday’s -$0.62),
  • bluebird bio (BLUE +$0.16),
  • Chinook Therapeutics (KDNY -$0.14 after Wednesday’s +$1.13 after Tuesday’s +$0.25 and Monday’s -$0.14),
  • Ionis Pharmaceuticals (IONS -$0.14 after Wednesday’s +$0.05 after Tuesday’s -$0.31 and Monday’s +$0.52),
  • Solid Biosciences (SLDB -$0.13 after Wednesday’s -$0.12 after Tuesday ’s -$0.09 and Monday’s -$0.29),
  • Homology Medicine (FIXX -$0.13 after Wednesday’s +$0.06 and Tuesday’s -$0.04),

Flat (4):

  • Agenus (AGEN),
  • Biostage (OTCQB: BSTG),
  • Editas Medicine (EDIT),
  • Fate Therapeutics (FATE)

Closing Up (12 of 12):

  • Intellia Therapeutics (NTLA +$3.24 after Wednesday’s +$0.58 after Tuesday’s +$0.78 and Monday’s +$1.65)
  • Verve Therapeutics (VERV +$1.97 after Wednesday’s -$0.81),
  • CRISPR Therapeutics (CRSP +$1.47 after Wednesday’s -$1.60 after Tuesday’s +$0.16 and Monday’s +$1.14)
  • BioLife Solutions (BLFS +$0.49 and Wednesday’s -$0.46),
  • Beam Therapeutics (BEAM +$0.31 after Wednesday’s -$1.74 and Tuesday’s +$1.25),
  • Vericel (VCEL +$0.24 and Wednesday’s -$0.42),
  • Sage Therapeutics (SAGE +$0.08 after Wednesday’s +$0.21 and Tuesday’s +$0.63),
  • uniQure NV (QURE -$0.08 after Wednesday’s +$0.56 after Tuesday’s -$0.04 and Monday’s +$1.04),
  • AxoGen (AXGN +$0.07),
  • Avrobio (AVRO +$0.05 after Wednesday’s +$0.03 and Tuesday’s -$0.02)

 

Q1/23 – March

  • Thursday closed negative with 12 incliner, 19 decliners and 4 flats
  • Wednesday closed negative with 12 incliner, 22 decliners and 1 flat

 

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

The cell and gene therapy sector has struggled as economic data piled up slowing share pricing as the overall economy – I believe canceled the costs of living unleashing damage to the sector.

The rush of Q4 and FY22 earnings to release is on … I do NOT believe there aren't a lot of cell/gene therapy companies in position yet – UNTIL earnings (Q4 and FY22) are reported – any breakout is a false hope with the inevitable downside re-occurring.

15 of my 35 covered have reported.

Upcoming Q4 earnings reporting will present challenges to share pricing.

·         Voyager Therapeutics (VYGR) 3/7 – Tuesday

·         Cellectis SA (CLLS) 3/9 - Thursday

·         Agenus (AGEN) 3/14 -Tuesday

·         AxoGen (AXGN) 3/14 Tuesday

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.

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.

Reiterating “Investors should recognize inflation may not return to normal levels begetting more volatility and DIPPING and CHOPPY sector share pricing.”

Biostage (OTCQB: BSTG)

Wednesday closed flat again on Thursday after Wednesday with 71 shares traded after Tuesday’s flat 5,601 shares traded <an example of a Ponzi scheme ???> on Tuesday after Monday’s -$0.20 with 382 shares traded. <3-month average volume = 1,328 shares>

·         David Green, CEO and Chairman of Board did accomplish ONE THING – he was able to shift LIABILITY of $5 M death suit (enabled Paolo Macchiarini artificial organ lawsuit) after he made the decision and were PERSONALLY LIABLE to SHAREHOLDERS …???

·         This IND – now almost 4 years old without a clinical trial that will last 3-5 years for ADULT patients before BSTG can EVEN consider a pediatric venue!

·         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??

 

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.