November 14, 2022 8:12am

What’s next … I still believe many cell and gene therapy equities are overbought

Earnings: Brainstorm Cell Therapeutics (BCLI) on Monday, 11/14

Indications:  1 Sell into Strength, 5 Negative Indication, 1 positive Indication and 1 Pump/Promote

A daily report may say little or a lot and its final judgement may be inconclusive; yet it serves as insurance that all indications are being examined, evaluated and reported.

I don’t seek fame, do podcast or give speeches, what I do is keep writing 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 - truth!

8:00 a.m. edition

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 -0.14% or (-49 points), S&P futures are DOWN -0.24% or (-9 points) and NASDAQ futures are DOWN -0.42% or (-49 points) early in the pre-open – so far,

Stock futures traded lower Monday

European stocks inched higher

Asia-Pacific markets are mixed as most are falling



We need to understand the macro to comprehend the micro re “our” universe of cell and gene therapy companies

Indexes closed positive on Friday … the Dow closed UP +33.91 points (+0.10%), the S&P closed UP +36.68 points (+0.93%) while the Nasdaq closed UP +209.18 points (+1.88%)

My quote of the a.m., Fed Governor Christopher Waller said Sunday that, “We’re at a point we can start thinking maybe of going to a slower pace.” But, “we’re not softening. ... Quit paying attention to the pace and start paying attention to where the endpoint is going to be. Until we get inflation down, that endpoint is still a way out there.”


Friday’s (11/11) … RegMed Investors’ (RMi) closing bell: “closing out the week booking gains. The sector pumped the upside even as I feel it was overbought as earnings LPS (loss-per-share) season continues; I do NOT belief that some type of bottom is being put in the sector” …


Ebb and flow:

Q4 – November - 6 negative and 4 positive closes

·         October -1 neutral, 11 positive and 9 negative closes

Q3/22 –

·         September – 1 holiday, 10 positive and 11 negative closes

·         August – 1 neutral, 11 positive and 11 negative closes

·         July - 1 holiday, 10 negative and 10 positive closes


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

SELL into Bare Strength: headed into a deabilitating ofering ...

Avrobio (AVRO) closed up +$0.0788 to $0.39 after Thursday’s $0.00 with a positive +$0.00 or +0.09% pre-open indication with earnings release with a net loss of -$23 million or -$0.52 per share and a cash position of $116 million with a runway until Q4/23. Notice the filing of an S-3 (11/8/22) with a draft prospectus by Cowen – a screw-job for early and present investors – they are being wiped-out by management! Check website! Also note, today is AVRO 55th session under Nasdaq’s delisting notice.


Positive Indications: still a believer

Agenus (AGEN) closed up +$0.06 to $2.51 with a positive +$0.12 or 4.78% pre-open indication,


Negative Indications: 

bluebird bio (BLUE) closed up +$0.43 to $7,52 after Thursday’s +$0.87 with a negative -$0.23 or -3.06% indication

Ultragenyx Pharmaceuticals (RARE) closed down -1.03 to $36.55 after Thursday’s +$3.86 with a negative -$1.09 or -2.98% indication

Vericel (VCEL) closed up +$1.39 to $23.80 after Thursday’s +$4.76 with a negative -$1.19 or -5% indication

CRISPR Therapeutics (CRSP) closed up +$5.66 to $60.35 after Thursday’s +$5.76 with a negative -$0.75 or -1.24% indication

BioLife Solutions (BLFS) closed up +$0.37 to $25.07 after Thursday’s +$7.40 with a negative -$0.75 or -2.99% indication


Puff/Pump and Promote: Maintaining SELL

Biostage (OTCQB: BSTG) closed flat with 8 shares traded to $6.19 after Thursday’s -$0.58 with 160 shares traded, Wednesday’s -$0.01 with 314 shares traded, Thursday’s +$0.76 with 1,880 shares traded and last Friday’s +$0.01 with 2,953 shares traded <3-month average = 2,443 shares>

A DRAFT prospectus is filed … SEC Form S-1/A  … . Questions arise as to draft prospectus statement of non-reliance of past financials?  Hey, CFO Joe some of us have copies of lost “payables”?


The Bottom Line: We are still in earnings season; focus is on “runways” or cash positions: who’s got it, what's being spent (i.e., losses), who doesn’t, and when will cash tight run-out.

With capital markets closed or tight, companies better be conserving.

Reiterating, “I try to keep it simple … and short …

What changes … “No one company is immune in the sector and this market of rolling downdrafts?”

Reiterating, “Kenny Storch at BTIG, states there are 226 public biotech companies trading below cash currently; with 1 out of 5 in the Nasdaq Biotech Index trading below cash.”

What’s SAFE …

Is it a sign of the times for a few gene therapy companies to end-up like RUBY (Rubius Therapeutics – seeking “strategic alternatives”, AGTC – running out of money – getting acquired by shell, AVRO and VSTM with delisting hanging over their head like a sword of Damocles (?) or BEAM (Beam Therapeutics (dropping trial) or even Verve Therapeutics (VERV) getting IND halted by FDA.

Faze Medicines, a neuroscience-focused startup that spun out of Third Rock Ventures in late 2020, is winding down. Clovis Oncology, a maker of cancer drugs, will likely file for bankruptcy protection due to dwindling sales of its sole product, mounting financial losses, and a crushing debt load.

Let’s not, forget Thursday’s FDA refusal of Brainstorm Cell Therapeutics (BCLI) BLA filing as its share price fell. …

WHO or WHICH are NEXT …?

Avrobio (AVRO) who experiences news and the stock drops after a de-listing notice while the management DID NOTHING to AVOID this dilemma while president, CEO and director Geoff Mackay carries home a HUGE salary of $754.39 K per year?

•             AVRO is NOT close to the $1.00 to continue its Nasdaq listing after a delisting notice.

•             What is the solution to “solve” the de-listing “position” on Nasdaq …?

AVRO has filed a DRAFT S-3 prospectus to “commission" an OFFERING by Cowen to address its delisting?  

•             Let’s NOT forget … AVRO’s 54th session under $1.00 i.e., delisting


Isn’t this Verastem Oncology’s (VSTM) its 36th session of being UNDER $1.00 heading for de-listing under Nasdaq (NO notice yet).


When it comes time to invest or even hold onto an investment; I’d say … focus on what percentage ownership of stock … NOT options CEOs and management teams own versus their salary and bonus.

CEO salaries, spending within G&A are totally OUT-OF-WHACK; these are companies in early development stages and will be for years without products in most cases not like the tech companies, whose CEOs and management teams think sector management teams should be compared to for bi-weekly cash and “beanies”!


We’re still be seeing what November brought – Q3 earnings LPS (loss-per-share) season and a whole lot of economic indicators.

Q4 is HERE and we are back into Q3 earnings season which could be a minefield:

·         Still more on way to be announced.

Investors are still struggling … to HOLD-on for sector share pricing direction and wanted clarity of guidance in earnings … and TRIALS that are to begin in earnest

If you have gains, you might want to lock-in profit (if any) … before earnings season begins!

Insight is about understanding perception and also about putting into context what is relevant to expectation fulfillment


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.