May 12, 2022 7:38am

So far there are no real indications that the cell and gene therapy sector is near a bottom; as the risks of inflation remain high

Pre-open indications: 6 Upside Indications, 3 Downside Indication and 1 Puff/Pump/Promote

RMi outlines a daily bell ringing 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 DOWN -0.11% (-34 points), S&P futures are DOWN -0.19% (-7 points) and NASDAQ futures are DOWN -0.60% (-71 points) early in the pre-open – so far,


Stock futures slumped on Thursday morning as a sell-off continues

European stocks fell sharply,

Asia-Pacific stocks declined following losses stateside.



There’s some, maybe more upside on the way; hopefully, it is pointed to get the oversold “recognized” …

In regular trading Wednesday, the Dow fell -326 points, or -1.02%, the S&P 500 fell -655.87 points or lipped -1.65% while the Nasdaq dropped -373.43 points or -3.18%.

The Nasdaq is approximately -30% off its high.

Interesting of a view, “This week is interesting because the stock market declines have accelerated downwards, so the waterfall is accelerating but things that normally would corroborate a waterfall decline like yields or the VIX have not been,” Tom Lee of Fundstrat.” “The bond market’s actually been pretty stable even in the face of a hot CPI and the VIX actually has been falling.” <CNBC>

Economic Data Docket: investors will be looking out for the latest on jobless claims, which will be released at 8:30. They’re also looking forward to fresh data on the producer price index, which measures prices at the wholesale level.


RegMed Investors’ (RMi) closing bell: “sector pricing was taken to the woodshed and whupped. Technicals, fundamentals and many 52-week lows are being ignored while gene editors are feeling the biggest share pricing pain. Risk equities are under-pressure as investors lose patience but, cannot ignore the headline of inflation number coming in higher as algorithms stripped the upsiders” …

Ebb and flow –

Q2/22 –

May - 4 positive and 4 negative 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

RegMed Investors (RMi) - Q1/22 Cell and Gene Therapy Earnings Scorecard Results …



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

Upside Indications and some WHYs:

Maintaining Position:

Agenus (AGEN) closed up +$0.14 to $1.66 <52-week low of $1.50> with a positive +$0.04 or +2.65% pre-open upside indication. Positive news from earnings’ report - Gilead (GLD) has an exclusive option to license AGEN2373, while AGEN can opt-in for a 50:50 profit share and US co-commercialization rights and can also received $5M milestone payment with up to $570 million in future potential option fees and milestones. Garo Armen, PhD, Chairman and CEO stated “Needless to say, we are also taking decisive steps to contain costs across the board despite our reasonable cash position.” Smart move in this environment.

Beam Therapeutics (BEAM) closed down -$5.82 to $29.96 <52-week low of $29.56> after Tuesday’s +$2.49 to $35.78 with a positive +$2.03 or +6.78% pre-open upside indication. BEAM shares have lost about 55.2% since the beginning of the year versus the S&P 500's decline of -13.5%. BEAM has a Q1 positive earnings surprise of $1.01 versus estimate -$1.10 and posted revenues of $8.43 million for Q1/22, missing the Zacks Consensus Estimate by -89.89%. market forces have NOT been good for gene editors. Cash position was $1.2 B, with a net loss of -$69.2 M for Q1/22, or $1.01 per share.

BioLife Solutions (BLFS) closed down -$1.21 to $10.54 after Tuesday’s +$0.85 <52-week low of $10.74> with a positive +$0.52 or +4.93% pre-open upside indication, BLFS affirms 2022 revenue guidance of $159.5 million to $171.0 million, reflecting year-over-year growth of 34% to 44% and organic growth of 28% to 39%. BLFS’ shares have lost about 67.2% since the beginning of the year versus the S&P 500's decline of -13.5%.

Caribou Biosciences (CRBU) closed down -$0.66 to $6.63 <52-week low of $6.54> after Tuesday’s +$0.62 after Monday’s -$0.66 after Friday’s $7.33 and last Thursday’s $7.78 following the previous Wednesday’s $8.34 with a positive +$0.34 or -1,53% upside pre-open indication,

CRISPR Therapeutics (CRSP) closed down -3.64 to $43.67 <52-week low of $42.99> after Tuesday’s +$4.08 after Monday’s -$4.78 after Friday’s $48.01, Thursday’s $51.34 and last Wednesday’s $55.62 with a positive +$0.23 or +0.53% upside pre-open indication.  CRSP reported Q1/22 net loss per share of $2.32, wider than the Zacks Consensus Estimate of a loss of $1.91; also, revenues substantially missed. Shares of CRSP have plunged 43% so far 2022 compared with the industry’s 25% decline.

Fate Therapeutics (FATE) closed down -$2.31 to $21.44 <52-week low of $21.18> after Tuesday’s +$1.40 after Monday’s -$1.81 with a positive +$1.07 or +$4.97% pre-open upside indication. An oversold bounce possible.


DOWNSIDE Indications:

Editas Medicine (EDIT) closed down -$1.23 to $10.03 <52-week low of $10.25> after Tuesday’s +$0.15, Monday’s -$2.55 to $11.11, Friday’s $13.66 and last Thursday’s $14.56 following the previous Wednesday’s $15.81 with a negative -$0.13 or -1.30% pre-open upside indication. EDIT incurred a loss of -$0.74 per share in Q1/22, narrower than the Zacks Consensus Estimate of a loss of -$0.81. EDIT shares have plunged -46.6% in 2022 compared with the industry’s decrease of -21.4%.

Intellia Therapeutics (NTLA) closed down -$4.46 to $39.94 <52-week low of $39.44> after Tuesday’s +$2.95, Monday’s -$6.12, Friday’s -$2.46 <52-week low of $41.12> and last Thursday’s -$5.67 following the previous Wednesday’s $3.92 with a negative -$0.01 or -0.03% pre-open downside indication. NTLA incurred a loss of $1.96 per share for Q1/22, wider than the year-ago loss of -$0.69 cents as well as the Zacks Consensus Estimate of a loss of -$1.11. Shares of NTLA have plunged 57.7% in the year so far compared with the industry’s 22.7% decline. Could or should be a BOUNCER.

Sage Therapeutics (SAGE) closed down -$0.76 to $29.34 <52-week of $27.36> after Tuesday’s +$2.58 with a negative -$0.44 or +5.13% pre-open downside indication.


Puff/Pump and Promote: Maintaining SELL

Biostage (OTCQB: BSTG) closed flat again with 0 shares traded <52-week low of $1.11> after Tuesday’s flat with 1,845 shares traded, Monday’s -$0.39 with 6,422 shares traded, Friday’s flat at $6.00 and last Thursday’s +$0.49 to $6.00 with 628 shares traded following the previous Wednesday’s -$0.36 with 5,171 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: I STILL think FEAR pervades this market and earnings’ reporting sector; it’s been a panic or race to escape the devastation.

I am PRAYING that the ill-tempered ALGORITMIC rules are in my favor today.

Weakness has also been driven by earnings’ reporting, the lack of sentiment, conviction and confidence enhanced by volatility.

This inflation induced market correction and Nasdaq dive show “so-so” signs of slowing as the 52-week lows are become OVERWHELMING!

Wednesday’s 52-week and some all-time lows:

  • uniQure NV (QURE) at $13.21,
  • Fate Therapeutics (FATE) at $21.30,
  • XBI at 63.15,
  • Adverum Biotechnologies (ADVM) at $0.99,
  • Sangamo Therapeutics (SGMO) at $3.57,
  • Mesoblast (MESO) at $3.29,
  • Ultragenyx (RARE) at $50.39,
  • Intellia Therapeutics (NTLA) at $39.45,
  • bluebird bio (BLUE) at $3.27,
  • Editas medicine (EDIT) at $10.25,
  • Global Blood Therapeutics (GBT) at -$22.77,
  • Regenxbio (RGNX) at $19.28,
  • Beam Therapeutics (BEAM) at $31.50,
  • Caribou Biosciences (CRBU) at $6.96,
  • Verastem Oncology (VSTM) at $1.02,
  • Precigen (PGEN) at $1.25,
  • AVROBIO (AVRO) at $0.76,
  • Cellectis SA (CLLS) at $2.95,
  • Solid Biosciences (SLDB) at $0.47,
  • Applied Genetic Technologies (AGTC) at $0.62,

To me, it says – NO bottoms are in sight as the Nasdaq undercut 2022’s lows, killing their one-day "rallies."

Also consider, “The CBOE's VIX index, also known as the 'fear gauge', eased 2.6% from the highest levels since early March, but was still notably elevated at 32.14 points.” <TheStreet>

Repeating, "We're going to see more volatility. This is not going to be an easy path forward as we still have a lot of unknowns," Omar Aguilar, Schwab asset management CEO and chief investment officer, told Yahoo Finance Live on Tuesday. "There's still a lot of uncertainty in many parts, not just in the macroeconomic and the economic structure, but also just geopolitically, things that haven't been resolved, like the war in Ukraine as well as just the COVID situation in China." <Yahoo! finance>

As I continue to maintain, “State the obvious, investors are NOT in control of daily market driven sector appreciation or downward dives.”

Q1/22 earnings season is half completed (24 of 35 reported) having reported LPS (loss-per-share) results so far MISSING estimates and revenues.

Reiterating, I am STILL NOT trusting 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 continue… the earnings “black hole next week

I try to keep it simple … and short!

Earnings’ season is upon us with: Brainstorm Cell Therapeutics (BCLI) on 5/16 and Cellectis SA (CLLS) on 5/13, 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.