May 2, 2022 7:45am

Q1/22 Earnings, churnings with a sentiment burn bag of (LPS) loss-per-share pricing – a NO support month unless clinical progress NEWS and throw-in of a relevant M&A

Earnings’ this week: uniQure NV (QURE) today,  Sage Therapeutics (SAGE) on 5/3, AxoGen (AXGN), Fate Therapeutics (FATE), Global Blood Therapeutics (GBT), Ionis Pharmaceuticals (IONS), MiMedx (MDXG), Editas Medicine (EDIT) and Vericel (VCEL) on 5/4; Sangamo Therapeutics (SGMO) and Ultragenyx Pharmaceuticals (RARE) on 5/5

Pre-open indications: 5 Upside Indication, 3 Downside Indications and 1 Pimp/Pump/Promote

RMi outlines a daily bell weather of “indications” about what you need to know; it’s what could happen or materialize after the opening and what might happen during the session.

Just the facts … I ask questions and note the indications of what could happen …

Remember that overnight and pre-open actions in futures don't necessarily translate into actual trading in the coming day’s session.


Dow futures are UP +0.29% (+96 points), S&P futures are UP+0.21% (+8 points) and NASDAQ futures are UP+0.25% (+33 points) early in the pre-open – so far,


U.S. stock index futures were higher during early morning trading on Monday after the Nasdaq Index posted its worst month since 2008,

European markets started the month of May on a weaker footing, with investors worried over monetary policy, inflation data, and sharp moves in U.S. markets,

Asia-Pacific markets cratered after data released over the weekend showed Chinese factory activity contracted in April; alongside Japan and South Korea. Markets in Hong Kong, mainland China, Singapore and Taiwan were closed on Monday for a holiday.



“The stock market correction intensified last week, as the major indexes sold off again, plunging into Friday's close. Two market rally attempts failed almost as soon as they started. Investors should stay nearly or entirely on the sidelines until the market offers clear signals of a sustained uptrend.” <IBD>

The big event this week for investors is the Federal Reserve meeting on May 3-4. Policymakers almost certainly will hike interest rates by 50 basis points and are expected to agree to start cutting the central bank's massive balance sheet.

Sector earnings this week – UG!


RegMed Investors’ (RMi) closing bell: “RegMed Investors’ (RMi) closing bell: the cell and gene therapy sector dives, TGIF and April is over” …

Ebb and flow –

Q2/22 –

May – second day, first session

·         April - 1 holiday, 6 positive and 13 negative closes


·         March – 13 negative and 10 positive closes

·         February stats: 11 negative, 8 positive closes and 1 holiday

·         January stats: 2 holidays, 1 neutral, 13 negative and 6 positive closes


Companies in my headlights – It’s your decision; I provide ideas and context: INDICATIONS

Possible Reversal of the curse of downtrodden markets, some companies deserve a lift … Upside indications:

Caribou Biosciences (CRBU) closed down-$0.08 to $7.40 <52-week low of $7.04 and a high of $32.65> with a +$0.12 or +1.62% pre-open indication,

Beam Therapeutics (BEAM) closed down -$2.04 to 37.53 with a positive +$0.47 or +1.25% pre-open indication,

CRISPR Therapeutics (CRSP) closed down -$2.00 to $49.62 <52-week low of $48.38> with a positive +$1.14 or +2.30% pre-open indication,

Editas Medicine (EDIT) closed down -$0.60 To $13.24 <52-week low of $12.90 and a high of $73.03> with a positive +$0.45 or +$3.40 pre-open indication,

IntelliaTtherapeutics (NTLA) closed down-$1.26 to $49.03 with a positive +$0.81 or +1.65% pre-open indication


Maintaining Downside Indication:

BioLife Solutions (BLFS) closed down -$0.34 to $12.67 after Thursday’s +$0.28 <52-weeklow of $12.13 and a high of $63.87> with a negative -$0.14 or-1.10% pre-open indication.

Global Blood Therapeutics (GBT) closed down again -$1.33 after Thursday’s -$0.31 <a 52-week low of $24.61 and a high of $42.47> with a negative -$0.35 or -1.14% pre-open indication.

Ultragenyx (RARE) closed down-$0.48 to $70.69 <252-weeklow of $61.21 and a high of 119.54> with a negative -$0.69 or -0.98% pre-open indication. Earnings this week.


Pimp/Pump and Promote:

Biostage (BSTG) closed up +$0.10 with 2,819 shares traded after Thursday’s flat at $5.90 with 1,905 shares traded following Wednesday’s -$0.30 with 1,150 shares traded, Tuesday’s -$0.30 with 25,325 shares traded and last Monday’s +$0.05 with 1,227 shares trading.

  • WARNING:  A terminal death lawsuit that just got settled (4/28) for $6 M by a “broke” company with yet another preferred convertible debt financing?
  • A “ZOMBIE” company, WHY BUY this equity with a 3-year-old IND, NO clinical trial initiation, and a precarious financial position dependent on a possible cash infusion? Also, WHY the pump of the volume to gain share appreciation – they have to reverse the multiple private placements (the priciest was $4.71) for a potential/proposed stock offering.
  • Last question: Has BSTG filed their FDA annual report on their IND – it needs to explain why it has not gone forward to date and their plan to go forward?


The BOTTOM LINE: Don't get sucked into morning rallies …

Last month ended and I am NOT trusting the beginning of the month of May – too many earning releasees.

Market/sector breadth is anemic, with losers outpacing winners and new lows trouncing new highs.

In this environment, it's impossible to call the bottom …

So, brace for more choppiness in the near-term as we enter… the earnings “black hole beginning this week

Reiterating, “I am NOT a sector optimist in light of current macro earnings and the coming “swarm” of cell and gene therapy sector in our very own “loss-per-share” companies reporting season.” The earnings are coming, the earnings are coming; flash the signal light of loss per share - I maintain a warning to investors to reduce exposure.

I try to keep it simple … and short!

Investors should consider taking at least partial profits quickly on winners to avoid round-tripping moves.

I am still, in the here and now, the cell and gene therapy sector will continue to “flutter”; as we are about to enter the earnings’ zone!

Two (2) sector earnings (ALNY and SLDB) from my covered list and they are BOTH charging their equity pricing into the ground.

Earnings’ season is upon us with Sage Therapeutics (SAGE) on 5/3 and AxoGen (AXGN), Fate Therapeutics (FATE), Global Blood Therapeutics (GBT), Ionis Pharmaceuticals (IONS), MiMedx (MDXG), Editas Medicine (EDIT) and Vericel (VCEL) on 5/4; Sangamo Therapeutics (SGMO) and Ultragenyx Pharmaceuticals (RARE) on 5/5, Agenus (AGEN) on 5/10 and Brainstorm Cell Therapeutics (BCLI) on 5/16 so far.


Whether information or intelligence is good, bad or somewhere in between; RMi’s daily report is a primer that may say little or a lot; yet it serves as insurance that all indications are being examined and evaluated.


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.

All investments are subject to risks. Investors should consider investment objectives.

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.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions securities referred to in this publication.