February 14, 2023 7:41am

There are four (4) phases of the stock cycle: accumulation; markup; distribution; and markdown

Pre-Open Indications: 3 Positive Indications, 2 Sell into Strength and 1 Negative Indication

News:  Verve Therapeutics (VERV) announced that VERVE-101 has been awarded the Innovation Passport for the treatment of heterozygous familial hypercholesterolemia (HeFH) under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory body of the United Kingdom (UK). The ILAP aims to accelerate time to market and facilitate patient access to innovative medicines. <more below>

It’s an honor to be considered the “canary in the (sector) coal mine”! It’s more than opinion, the facts and truth need to be recognized!

I write 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 about - truth! 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 +0.08% or (+26 points), S&P futures are UP +0.22% or (+9 point) and NASDAQ futures are UP +0.40% or (+50 points) early in the pre-open – so far

Stock futures were inching higher Tuesday morning,

European markets were slightly higher,

Asia markets were mixed.

 

Henry’omics:

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

Indexes ascended after suffering weekly declines in multiple months. The Dow closed UP +377.05 points (+1.11%); the S&P closed UP +46.94 points (+1.15%) while the Nasdaq closed UP +173.67 points (+1.48%)

Indexes came off a winning session, with all three major indexes ending Monday’s session up more than 1% after posting their worst weekly performances since December.

Economic Data Docket: The CPI inflation report, will it define the Fed rate hike

  • “Economists polled by Dow Jones expect CPI rose 0.4% from December, and they predict the index climbed 6.2% compared to the prior year.”
  • “Core CPI, which excludes food and energy, is expected to rise 0.3% from the prior month and 5.5% compared with the same month a year ago.” <CNBC>

 

News (continued): Verve Therapeutics’ (VERV) VERVE-101 is a novel, investigational gene editing medicine designed to be a single-course treatment that permanently turns off the PCSK9 gene in the liver to durably lower disease-driving low-density lipoprotein cholesterol (LDL-C). Innovation Passport is the first step in the ILAP process and is awarded for a medicinal product addressing a condition that is life-threatening or seriously debilitating and where there is a significant patient or public health need.

  • People suffering with HeFH face the life-threatening consequences of lifelong very high levels of LDL-C and only about 3% of HeFH patients worldwide are actually at treatment goal. This is often due to the heavy treatment burden of the chronic care model requiring daily statins and/or intermittent injections, often over decades,” said Sekar Kathiresan, M.D., co-founder and chief executive officer of Verve.

 

Monday’s (2/13) … RegMed Investors’ (RMi) closing bell: “the sector’s upside bounce was expected. Love ‘em or hate them, algorithms and electronic trading moved the sector upward on Monday” … https://www.regmedinvestors.com/articles/12831

 

Ebb and flow:

Q1/23 – February – 5 negative and 4 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

Positive Indications:

Brainstorm Cell Therapeutics (BCLI) closed down -$0.322 to $2.60 with a positive +$0.12 or +4.62% aftermarket indication.

CRISPR Therapeutics (CRS) closed up +$1.73 to $51.51 after Friday’s -$1.30, Thursday’s -$2.31 and Wednesday’s -$2.28 with a positive +$0.80 or +1.55% pre-open indication

Verve Therapeutics (VERV) closed up +$0.69 to $21.14 with a positive +$0.86 or +4.07% pre-open indication on news.

 

Negative indications:

Sage Therapeutics (SAGE) closed up +$0.27 to $45.28 after Friday’s +$0.21 and Thursday’s -$0.01 with a negative -$0.30 or -0.66% aftermarket indication

 

Sell into Strength:

Prime Medicine (PRME) closed up +$1.30 to $21.02 after Friday’s +$0.54 with a positive +$0.17 or -0.81% aftermarket indication.

Intellia Therapeutics (NTLA) closed up +$1.35 to $41.32 after Friday’s -$1.13, Thursday’s -$2.01 and Wednesday’s -$1.71 with a positive +$0.68 or +.65% pre-open indication.

 

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

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.”

The sector “gyrate” as algorithms and electronic trading satisfy the lust for returns in quant and hedge funds. 

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.

·         Sage Therapeutics (SAGE) 2/16 – Thursday

·         Ionis Pharmaceuticals (IONS) 2/22 – Wednesday

·         Ultragenyx Pharmaceuticals (RARE) 2/22- Wednesday

·         Ionis Pharmaceuticals (IONS) 2/22 - Wednesday

·         Alnylam Pharmaceuticals (ALNY) 2/23 – Thursday

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

·         Fate Therapeutics (FATE) 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.

 

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.