November 8, 2022 7:46am

Bring-it; as earnings LPS (loss-per-share) releases continue to frame the sector; any market or even sector reaction will likely hinge on whether Republicans take back the House of Representatives, the Senate or both.

Earnings today: Agenus (AGEN), AxoGen (AXGN), Voyager Therapeutics (VYGR), Avrobio (AVRO) and Sage Therapeutics (SAGE)

Indications: 3 Positive Indications, 3 Negative Indication Categories, 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 and evaluated.

Why do I keep writing this blog/newsletter to inform investors, what they need to hear that others won’t say or write! Insight is about understanding perception and also about putting into context what is relevant to expectation fulfillment

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 UP +0.14% or (+45 points), S&P futures are UP +0.16% or (+6 points) and NASDAQ futures are UP +0.47% or (+51 points) early in the pre-open – so far,

Stock futures were slighter higher Tuesday morning,

European markets were mixed,

Asia-Pacific markets were also mixed ahead of U.S. midterm elections.



Indexes rose Monday with senate and congressional midterm elections and key inflation data on deck.

The Dow closed UP +423.78 points (+1.31%), the S&P closed UP +36.25 points (+0.96%) while the Nasdaq closed UP +89.27points (+0.85%)

Economic Data Docket: investors are anticipating Thursday’s CPI report will give further insight into the Federal Reserve’s efforts to squash inflation. A hot inflation report could signal to investors that a pivot from higher interest rates, for longer, could be further away than expected. <CNBC>


Monday’s (11/7) … RegMed Investors’ (RMi) closing bell: “election and economics will determine the week as negative momentum moves the sector today’ …


Ebb and flow:

Q4 – November - 5 negative and 1 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

Negative Indications:

Avrobio (AVRO) closed up +$0.0079 to $0.65 with a negative -$0.03 or -4.53% 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.

bluebird bio (BLUE) closed up +$0.68 to $6.81 with a negative -$0.05 or -0.73% pre-open indication. My question, “WHEN the offering”? bluebird bio (BLUE) had a Q3 net loss of -$76.52 million or -$0.94 per share with a cash position of $141 million (with $45 million restricted cash and $54 ATM utilization) and a Q2/23 runway.

Ionis Pharmaceuticals (IONS) closed up +$0.06 to $41.61, Friday’s -$2.94 and Thursday’s -$0.19 with a negative -$1.00 or -2.40% pre-open indication.


Positive Indications:

Caribou Therapeutics (CRBU) closed down -$0.31 to $9.03 with a positive +$0.12 or +1.33% pre-open indication.

Fate Therapeutics (FATE) closed down -$0.16 to $19.68 after Friday’s +$0.39, Thursday’s -$0.59 and Wednesday’s -$0.95 with a positive +$0.32 or +1.63% pre-open indication

uniQure NV (QURE) closed down -$0.38 to $18.86 with a positive +$0.94 or +4.98% pre-open indication.


Puff/Pump and Promote: Maintaining SELL

Biostage (OTCQB: BSTG) closed up +$0.76 with 1,880 shares traded after Friday’s +$0.01 with 2,953 shares traded, Thursday’s -$0.09 with 800 shares traded, Wednesday’s -$0.05 with 100 shares traded, and last Tuesday’s flat with 963 shares traded following the previous Monday’s -$0.85 with 2,100 shares traded <3-month average = 2,446 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: The sector suffered significant damage this past week and on Monday, with share pricings tumbling.

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?”

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.

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.

WHO or WHICH are NEXT …?

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

We will be seeing what November brings – 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:

·         Ionis Pharmaceuticals (IONS), Precigen (PGEN) and Vericel (VCEL) on Wednesday, 11/9

·         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!

Sentiment sensitive cell and gene therapy stocks are especially vulnerable.

Legendary investor Jeremy Grantham warns the current market backdrop is among the worst he's ever seen - and says holding cash is a good idea. The veteran investor also confirmed he's betting against the Nasdaq index and high-yield or "junk" bonds, suggesting he expects tech stocks to continue dropping, and corporate defaults to spike. <had an office next door to him, many years ago – a god of markets>

DISPOSE of 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.

·         Where is the upside coming from to “solve” the de-listing “position” on Nasdaq?

·         Will AVRO have to “commission" a stock reverse to address its delisting?

·         OR, will they “pull” an AGTC?

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.

Amid the ongoing cell and gene therapy sector volatility, “our” universe’s trend remains " in a constant correction." That means that investors are safer on the sidelines as again … earnings are coming.

My guide to 'good news seems to be bad news' and 'bad news is good news. 'In normal times, no one really questions whether good news in the economy is actually good.


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.