February 22, 2023 7:33am

Pre-Open Indications: 6 Positive Indications and 2 Negative Indications

News: Sage Therapeutics (SAGE) the European Medicines Agency (EMA) granted Orphan Drug Designation to SAGE-718 for the treatment of Huntington’s disease (HD). SAGE-718 is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction.

Earnings: Editas Medicine (EDIT), Ionis Pharmaceuticals (IONS) and Sangamo Therapeutics (SGMO)

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.

Subscription is coming, it’s not conscription but, an offer to join our collective of like-minded investors!  Join me … in the NO spin zone.

The 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. My interpretation of the morning’s numbers is written to be informative; it’s built on will happen behind the headlines today, not tomorrow or yesterday …

 

Dow futures are UP +0.11% or (+37 points), S&P futures are UP +0.09% or (+3 point) and NASDAQ futures are UP +0.11% or (+13 points) early in the pre-open – so far

Stock futures were fluctuating up after downward spiral on Wednesday

European markets were lower,

Asia pacific markets also were lower.

 

Henry’omics:

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

Indexes dropped Tuesday as higher rates continue to pressure sentiment, and the latest batch of retail earnings raised concern about the state of the consumer. NYSE and Nasdaq volume surged well above Friday levels.

The Dow closed DOWN – 697.10 points (-2.06%); the S&P closed DOWN -81.75 points (-2%) while the Nasdaq closed DOWN -294.97 points (-2.50%)

“Mounting concerns that the Federal Reserve will continue hiking rates spooked investors during regular trading Tuesday and pushed stocks to cap off their worst day of 2023.” <CNBC>

Economic Data Docket: minutes detailing discussion at the Fed's last policy meeting, for further clues on attitudes within the central bank on rates.

 

Tuesday’s (2/21) … RegMed Investors’ (RMi) closing bell: “extending losses as fear defines the cell/gene therapy sector with Q4 and FY22 earnings release bringing more pressures. Sentiment is non-existent as even electronic trading and algos resist the capacity to interfere to prop the sector.” … https://www.regmedinvestors.com/articles/12842

 

RegMed Investors (RMi) Research Note: Q4 and FY22 earnings reporting … “The cell and gene therapy sector fluctuates in revenues, collaboration, regulatory submissions and expenses, but the changes may alarm investors who prefer to see expectation and consensus stability and share pricing growth” … https://www.regmedinvestors.com/articles/12843

 

Ebb and flow:

Q1/23 – February – 1 holiday, 8 negative and 6 positive closes

·         January – 2 holidays, 11 positive and 9 negative closes

 

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

Maintaining Negative indications:

Beam Therapeutics (BEAM) closed down -$3.82 to $39.35 after Monday’s holiday and Friday’s +$1.50 with a negative -$0.35 or -0.89% pre-open indication,

Vericel (VCEL) closed down -$1.21 to $28.61 after Monday’s holiday and Friday’s +$0.96 with a negative -$0.66 or -2.31% pre-open indication. VCEL reports W4 and FY22 earnings on Thursday, 2/23.

 

News affecting share pricing: a positive

Sage Therapeutics (SAGE) closed down -$2.79 to $42.73 with a negative -$1.23 or -2.88% aftermarket indication.

 

Positive indications:

BioLife Solutions (BLFS) closed down -$2.45 to $21.118 after Monday’s holiday and Friday’s +$0.88 with a positive +$0.43 or +2.03%.

CRISPR Therapeutics (CRSP) closed down -$4.26 to $46.63 with a positive +$0.59 or +1.27% pre-open indications. “CRSP stock increased slightly in extended action. CRSP reported a smaller-than-expected Q4 loss and said it's on track to finish its FDA submission by the end of Q1 for its gene-edited therapy to treat sickle cell disease and transfusion-dependent beta thalassemia. Crispr stock sank 4.8% on Tuesday to 62.07, knifing below the 50-day line.” <IBD>

Regenxbio (RGNX) closed down -$0.93 to $21.25 with a positive +$1.78 or +8.40% pre-open indication. Earnings on Tuesday, 2/28.

Ultragenyx Pharmaceuticals (RARE) closed down -$3.21 to $45.50 after Monday’s holiday and Friday’s +$4.44 with a positive +$0.34 or +0.75% pre-open indication.

uniQure NV (QURE) closed down -$0.63 to $20.08 after Monday’s holiday after Friday’s +$0.55 with a positive +$1.06 or +5.28% pre-open indication following news of its partner, CSL (ASX: CSL), has received conditional marketing authorization (CMA) from the European Commission for HEMGENIX® (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B.

 

The BOTTOM LINE: I try to keep it simple and short!

The rush of Q4 and FY22 earnings to release is on … I do NOT believe there aren't a lot of cell/gene therapy companies in position yet – UNTIL earnings (Q4 and FY22) are reported – any breakout is a false hope with the inevitable downside re-occurring.

Maintaining my investing thesis, “Until the sector as well shows some strength, investors should be careful about adding exposure. The recent pullbacks highlight the importance of adding exposure gradually, and not buying extended.”

Cell and gene therapy sector companies ended 2022 with dwindling cash positions and many candidates in development and, apparently, too many employees.  I foresee sector sees companies slashing programs, culling staff and reorganizing, which will make sector “participants” leaner with better cash “runways”. That will certainly be the case for 2023.

I also hate to be so negative or contrarian but, this is a NO spin zone and truth is its product.

And I can always be WRONG but, mostly EARLY!

Upcoming Q4 earnings reporting will present challenges to share pricing.

·         Alnylam Pharmaceuticals (ALNY) 2/23 – Thursday

·         Vericel (VCEL) 2/23 – Thursday’s

·         Intellia Therapeutics (NTLA) 2/23 - Thursday

·         Fate Therapeutics (FATE) 2/28 -Tuesday

·         MiMedx (MDXG) 2/28 Tuesday

·         Regenxbio (RGNX) 2/28 - Tuesday

So be cautious about adding exposure and stick to loss-cutting rules.

A couple of companies have become … black holes … of investor sentiment; yet, some get financing to continue the chain around investors’ necks until they recognize it could be forever with “some” of these equities.

I will be slipping away to a warmer climate next Thursday through the following Monday – keeping that tall blonde happy for yet another many a year!

 

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.