May 4, 2022 7:35am

Number of sector earnings and “Fed Day” with the policy announcement at 2 p.m. ET; so, don't be surprised by big swings in today’s session

Earnings: AxoGen (AXGN), Fate Therapeutics (FATE), Global Blood Therapeutics (GBT), Ionis Pharmaceuticals (IONS), MiMedx (MDXG), Editas Medicine (EDIT) and Vericel (VCEL)

Pre-open indications: 4 BUYs, 5 SELL into Strength 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 +0.40% (+136 points), S&P futures are UP +0.44% (+18 points) and NASDAQ futures are UP +0.37% (+48 points) early in the pre-open – so far,


Stock futures inched higher in early morning Wednesday – waiting for the Fed policy announcement,

European markets dived as the pan-European Stoxx 600 slid 0.6% by late morning,

Asia-Pacific stocks were lower as markets in Japan and mainland China were closed on Wednesday for holidays.



On Tuesday the Dow added 67.29 points or 0.20%, the S&P 500 gained 20.10 points or 0.48% as the Nasdaq also rose by 27.74 points or 0.22%.

Markets are preparing for the Fed policy announcement (that I believe has been built into this market), while the central bank is also expected to announce a plan to cut its roughly $9 trillion balance sheet by $95 billion a month, beginning in June.

Sector News: Another of Pfizer's (PFE) gene therapies has been freed from an FDA clinical hold, but the study is not set to get underway immediately. The FDA lifted its clinical hold of a phase 3 study called Affine for the hemophilia A gene therapy giroctocogene fitelparvovec in March. But Pfizer is maintaining a voluntary pause and will resume clinical activities in a few months, the company said during first quarter earnings Tuesday. The voluntary pause will stay in place until Pfizer has met all necessary conditions, including approval of updated study protocols by regulatory authorities. <Fierce Pharma>


RegMed Investors’ (RMi) closing bell: “anticipation versus expectation, waiting for the Fed and experiencing sector earnings. The cell and gene therapy sector opened and skipped to the downside, then flipped to the upside as volatility twisted. As I stated this a.m., “After yesterday’s (Monday) spike up, down and up again; another trip and fall without getting up?” Never totally wrong, more than frequently right!” …


Ebb and flow –

Q2/22 –

May - 2 positive closes

·         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

BUY on being Oversold:

Beam Therapeutics (BEAM) closed down -$0.75 to $40.03 after Monday’s +$3.25 < 52-week low of $36.31 and a high of $138.52> after Friday’s -$2.04 with a positive +$0.94 or +2.35% pre-open indication,

Caribou Biosciences (CRBU) closed down -$0.13 to $7.80 after Monday’s +$0.53 <52-week low of $7.04 and a high of $32.65> with a positive +$0.35 or +4.49% pre-open indication,

Fate Therapeutics (FATE) closed down -$0.99 to $28.78 <52-week low of $27.76 and a high of $97.43> after Monday’s $29.77, Friday’s $28.56, Thursday’s $31.65 and last Wednesday’s $31.87 with a positive +$0.39 or +1.36% pre-open indication Earnings today.


BUY post Earnings:

Sage Therapeutics (SAGE) closed up +$0.19 to $32.79 with a positive +$1.43 or +4.36% pre-open indication post earnings


SELL into Strength:

Alnylam Pharmaceuticals (ALNY) closed up +$3.84 to $142.89 <52-week low of $125.00 and a high of $212.00> after Monday’s +$5.62, Friday’s -$9.73 and last Thursday’s -$11.76 with a negative -$0.24 or -0.17% pre-open indication,

CRISPR Therapeutics (CRSP) closed up +$0.64 to $52.62 after Monday’s +$2.36 after Friday’s -$2.00 <52-week low of $48.38> and a high of $169.76> with a positive +$0.39 or +0.74% pre-open indication,

Pluristem (PSTI) closed up +$0.08 to $1.68 after Monday’s $1.60 and last Friday’s $1.52 with a negative -$0.19 or -11.312% pre-open indication,

Ionis Pharmaceuticals (IONS) closed up +$0.13 to $38.50 after Monday’s +$1.61 <52-week low of $25.04 and a high of $44.42> with a positive +$0.10 or +0.26% pre-open indication. Earnings today.

UniQure NV (QURE) closed up +$0.15 to $15.92 after Monday’s +$0.83 <52-week low of $14.29 and a high of $38.80> with a negative -$0.17 or -1.07% pre-open indication post earning with a drawdown of $65 M debt facility,


Pimp/Pump and Promote: Maintaining SELL

Biostage (OTCQB: BSTG) closed down -$0.12 with 3,350 shares traded after Monday’s $0.00 with 3,925 shares traded, Friday’s +$0.10 with 2,819 shares traded, Thursday’s flat at $5.90 with 1,905 shares traded, and last Wednesday’s -$0.30 with 1,150 shares traded.

  • 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.
  • One positive, Chairman and interim CEO Green shifted the burden of the death suit from management’s responsibility to shareholders with this new settlement with a debt financing.
  • Question didn’t Chairman and then CEO invite Paola Macchiarini, the individual responsible for the terminal death (to Harvard Apparatus, now Biostage) who is just going on trial in Sweden for similar but, aggravated assault reasons against patients?
  • Last question: Has BSTG filed their FDA annual report on their IND to the FDA – which defines its capacity and capability why it can go forward to a clinical trial and their CRO plan forward?


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

Reiterating, 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.

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!

Three (3) sector earnings (ALNY, SLDB and SAGE) from my covered list and two (2) dived while SAGE gained some altitude. QURE reported yesterday, Monday and popped +$0.83 – I’m taking a profit.

Earnings’ season is upon us with 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, BioLife Solutions (BLFS) on 5/9, 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.