February 21, 2023 7:52am

Will uncle “algo” salve the share pricing pain with his electronic friends and apply a share pricing bandage or let value bleed-out?

Pre-Open Indications: 5 Negative Indications

I am definitely considered a contrarian depending on the session – one has to be a watcher of the ups and downs as well as measurer of sentiment. I am also a NO trust investor but, a validate and verify journalist/analyst.

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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 DOWN -0.84% or (-283 points), S&P futures are DOWN -0.74% or (-230 point) and NASDAQ futures are DOWN -0.96% or (-120 points) early in the pre-open – so far

U.S. stock futures fell Tuesday,

European markets were lower,

Asia-Pacific markets were mixed.

 

Henry’omics:

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

Monday was a holiday after indexes were mixed on Friday as stubbornly high inflation and a rebound in rates continued to weigh on investor sentiment. The Dow closed UP +129.84 points (+0.39%); the S&P closed DOWN -11.32 points (-0.28%) while the Nasdaq closed DOWN -68.56 points (-0.58%)

Last week, the Dow ended down -0.13%, the S&P 500 shed -0.28% and the Nasdaq rose +0.59%.

Economic Data Docket: Personal Consumption Expenditures (PCE) price index — the Fed's most closely watched assessment of how quickly prices are rising across the economy — which is set for release Friday morning.

·         Prices in January likely jumped 0.5% over the prior month as measured by the PCE index, according to data from Bloomberg. in December PCE inflation rose just 0.1% month-on-month. On an annual basis, PCE inflation is projected to come in at 5% in January, no improvement from the year-over-year figure reported at the end of 2022.

·         The Fed on Wednesday is scheduled to release the minutes from its meeting of Jan. 31 and Feb. 1. The central bank hiked rates by 25 basis points after that meeting.

 

Friday’s (2/17) … RegMed Investors’ (RMi) closing bell: “a concluding weekly reverse as the oversold sector was recognized closing positive after a bad morning. Raising capital for sector needs a clear path not a pothole strewn share pricing runway.” … https://www.regmedinvestors.com/articles/12840

 

Ebb and flow:

Q1/23 – February – 1 holiday, 7 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

Negative indications:

Alnylam Pharmaceuticals (ALNY) closed up +$2.94 to $222.79 with a negative -$0.55 or -0.25% pre-open indication,

Intellia Therapeutics (NTLA) closed up +0.55 to $40.38 after Thursday’s -$1.95, Wednesday’s +$1.00 with a negative -$0.52 or -1.29% pre-open indication.

Verve Therapeutics (VERV) closed up +0.51 to $21.10 after Thursday’s -$1.13, Wednesday’s -$0.04, last Tuesday’s +$0.62 and the previous Monday’s +$0.69 with a negative -$1.10 or -5.21% aftermarket indication.

Beam Therapeutics (BEAM) closed up +$1.50 to $43.17 with a negative -$0.76 or -1.76% pre-open indication,

uniQure NV (QURE) closed up +$0.55 to $20.71 with a negative -$0.20 or -0.97% pre-open indication.

 

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

Sector needs more interest with and by pharma partnering.

Yet, GSK’s (formerly GlaxoSmithKline plc) vision to investors last month, CEO Emma Walmsley reaffirmed that the British Big Pharma had decided to “end our investment in cell and gene therapy.”

·         While this was hardly news to the audience—especially coming months after GSK axed cell therapy deals with Lycell and Immatics—it still served as a stark reminder that the company's development portfolio is swimming against the industry tide.

·         But rather than racing to get an “off-the-shelf” CAR-T into the clinic or going all-in on a solid tumor strategy, GSK believes its genetic expertise will offer the smoothest path to market success.

·         “About 70% of the entire GSK portfolio now has strong human genetic underpinning and even higher than that in the research phase,” the company’s head of research, John Lepore, M.D., tells Fierce Biotech in an interview.

·         The theory is that genetically validated targets have at least a twofold higher.”

While, Mesoblast (MESO; ASX: MSB), announced that the FDA Office of Tissues and Advanced Therapies (OTAT) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) associated with disc degeneration, in combination with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc.

·         RMAT designations aim to expedite the development of regenerative medicine therapies intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition where preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for the disease or condition. An RMAT designation for rexlemestrocel-L provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on filing of a Biologics License Application (BLA).

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 certainly will be the case for 2023.

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

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.

·         Ionis Pharmaceuticals (IONS) 2/22 – Wednesday

·         Editas Medicine 2/22 - Wednesday

·         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

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.