May 22, 2023 4:56pm

So much for seeking shelter or waiting 10 days for a hard deadline of debt ceiling negotiations

News:  Sangamo Therapeutics (SGMO +$0.07) the FDA has granted Fast Track Designation to isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. Alnylam Pharmaceuticals (ALNY +$2.32) announced new positive results from an interim analysis of exploratory data from the open-label extension (OLE) period of the P3 APOLLO-B study of patisiran for the treatment of transthyretin-mediated (“ATTR”) amyloidosis with cardiomyopathy. Blueprint Medicines (BPMC +$1.51) the FDA has approved AYVAKIT® (avapritinib) for the treatment of adults with indolent systemic mastocytosis (ISM). All U.S. patients with ISM now have access to the first and only approved medicine designed to treat their disease.

If you’re looking for sector intel, ideas and facts or Insight in a volatile climate, RMi defines the extenuating factors of share pricing.

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 DOWN -140.05 points (-0.42%), the S&P closed UP +0.65 points (+0.02%) while the Nasdaq closed UP +62.88 points (+0.50%)

 

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.

Monday’s moves brought the Nasdaq index to its highest close and highest intraday level since August.

“Both Biden and McCarthy have acknowledged that one of the main sticking points in the talks remains the question of spending caps, a key GOP demand but a red line so far for the White House. Raising the debt limit would not authorize new spending, but Republicans have push to cut government outlays as part of a deal to hike the borrowing limit.” <CNBC>

“While we’d like to say the worst is behind us, it isn’t,” <Morgan Stanley chief investment officer Lisa Shalett>.

 

Monday (5/22) … RegMed Investors’ (RMi) pre-open: “ominous doubts are growing; risk exposure needs to be examined. Shares and pricing as debt ceiling on-going “talks’ grapple to the mat anticipating a default?” … https://www.regmedinvestors.com/articles/12969

 

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

  • Monday’s advance/decline line opened positive at 29 up/ 4 down and 1 flat, stayed positive with 30 up/ 4 down and 1 flat at the mid-day, ending with a positive close of 29/4 and 2 flats

 

Key Metrics:

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

  • Monday, the IBB was up +0.82% and the XBI was up +2.46%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +0.39 points or +2.32% at 17.20

 

Closing Down (4 of 4):

  • uniQure NV (QURE -$0.29),
  • AxoGen (AXGN -$0.06),
  • Generation Bio (GBIO -$0.05),
  • Homology Medicine (FIXX -$0.02),

Flat (2);

  • Biostage (OTCQB: BSTG)
  • bluebird bio (BLUE)

Closing Up (10 of 29):

  • CRISPR Therapeutics (CRSP +$3.67),
  • Intellia Therapeutics (NTLA +$2.37),
  • Alnylam Pharmaceuticals (ALNY +$2.32),
  • Vericel (VCEL -$2.01),
  • Ionis Pharmaceuticals (IONS +$1.52),
  • Blueprint Medicine (BPMC +$1.51),
  • BioLife Solutions (BLFS +$0.83),
  • Ultragenyx (RARE +$0.81),
  • Chinook Therapeutics (KDNY +$0.79),
  • Voyager Therapeutics (VYGR +$0.68),

 

Q2/23 – May

  • Monday closed positive with 29 incliners, 4 decliners and 2 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.”

“The BIGGEST risk to the economy – the clock is ticking for a divided U.S. Congress to raise the federal government's debt ceiling, which currently stands at over $31 trillion but risks running out of cash as soon as June 1.

“Debt-ceiling negotiations are a lose-lose for equity investors at this point, as a failure to strike a deal will lead to an immediate recession, while a deal will strain liquidity from markets as the US Treasury issues trillions in new bonds, which are newly born.” <Jose Torres, Interactive Brokers>

As I have stated, “The cell and gene therapy sector is experiencing yet another “flight of Icarus” …  since “our” universe have oscillated between gains and losses since the first of 2023!”

There is VALUE out there however, it’s about playing or betting the timing of the sector. Even as I had stated, “I wouldn’t be buying into this rally … I would be selling into this upside!”

A very appropriate quote, “You don't do well by trying to be right; it is impossible for humans. You do well by figuring out when you're wrong faster than others do.” <Nassim Nicholas Taleb>

There are clear winners — and losers — at the start of May.

The top three (3) performing in the session:

·         Monday: CRISPR Therapeutics (CRSP), Intellia Therapeutics (NTLA) and Alnylam Pharmaceuticals (ALNY)

While The worst three (3) in the session:

·         Monday: uniQure NV (QURE), AxoGen (AXGN) and Generation Bio (GBIO),

 

Some good news: Ironwood Pharmaceuticals (IRWD) plans to buy VectivBio, a Switzerland-based biotechnology company focused on treating rare disorders, in an all-cash deal valued at around $1 billion. Terms hold that Ironwood will pay $17 for each VectivBio share, reflecting a 43% premium to the stock’s price at market’s close Friday. The transaction, which is expected to close sometime in the back half of this year. IRWD specializes in diseases of the stomach and intestines, and currently co-markets the irritable bowel syndrome drug Linzess alongside AbbVie. <Apraglutide is a next-generation GLP-2 analog currently in P3>

 

Earnings:

RegMed Investors (RMi) Research Note: Q1/23 earnings reporting dates, net losses, cash positions and runway outcomes … https://www.regmedinvestors.com/articles/12923  -

Sector earnings season have drawn to a close …

·         One (1) net income from 34 reported to date:

 

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.

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! U.S. public shareholders deserve accountability …

 

Biostage (OTCQB: BSTG) …

·         Monday closed FLAT after Friday closed FLAT with 23 shares traded, Thursday closed FLAT with 1,220 shares traded, Wednesday closed down -$0.31 with 951 shares traded, Tuesday closed flat with 27 shares traded and last Monday closed up +$0.32 with 326 shares traded <3-month average =1,490 shares>

·         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?

·         Accumulated deficit:  $85,901 M – still NO product in sight!

 

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.