February 1, 2023 7:39am

Will the cell/gene therapy sector be dependent or independent of market forces?

News: Mesoblast (MESO +$0.49 or +14.85% in aftermarket) has re-submitted to the U.S. FDA its Biologics License Application (BLA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Pre-Open Indications: 4 Positive Indications and 1 Negative Indication

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 DOWN -0.35% or (-120 points), S&P futures are DOWN -0.15% or (-6 point) and NASDAQ futures are barely UP +0.07% or (+9 points) early in the pre-open – so far

Stock futures are mixed and slipping Wednesday,

European markets were slightly higher,

Asia-Pacific markets traded higher

 

Henry’omics:

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

Indexes rose Tuesday to end the month …The Dow ended Tuesday nearly 369 points higher, rising by 1.09%; the S&P 500 gained 58.83 points or 1.46% and the Nasdaq rose +190.47 points or 1.67%.

The stock market rally rebounded Tuesday, recouping much of Monday's retreat.

Economic Data Docket: Ahead of the Fed meeting announcement Wednesday afternoon, several key economic reports and an OPEC+ meeting.

·         The ADP employment report for January will be out at 8:15 a.m. ET, with December job openings and the January ISM manufacturing index at 10 a.m. ET.

·         Could the Federal Reserve be set to slow rate hikes for a second straight meeting, increasing the fed funds rate by a quarter point at 2 p.m. to a 4.5%-4.75% range.

 

News (continued): Mesoblast (MESO) – New Data Show that Remestemcel-L Improves Inflammatory Biomarkers and Survival in Children at Highest Risk of Mortality. New 4-Year Data from the P3 Trial Shows Durable Long-Term Survival Outcomes

·         The resubmission contains substantial new information as required by FDA in the Complete Response Letter (CRL) received in September 2020 to the BLA for remestemcel-L.

·         Mesoblast has maintained an active dialogue with FDA since receiving the CRL and in October 2022 provided a high-level synopsis of the substantial new information under its Investigational New Drug (IND) application for remestemcel-L.

·         FDA granted remestemcel-L Fast Track designation, a process to facilitate the development and expedited review of therapies for serious conditions that fill unmet medical needs, and Priority Review designation, which is given to drugs that treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments.

·         The BLA resubmission will have a review period up to six months from filing upon acceptance by FDA.

 

Tuesday’s (1/31) … RegMed Investors’ (RMi) closing bell: a reverse from Monday’s depths. Last trading session of January raises question of February’s pricing future? As I have stated, “What goes up with ceremony, goes down with disdain followed by the opposite effect.” … https://www.regmedinvestors.com/articles/12811

 

Ebb and flow:

Q1/23 – February – first session

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

Q4/2022

·         December – 1 holiday, 13 negative and 8 positive closes

·         November -1 holiday, 14 negative and 8 positive closes

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

 

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

Risk is STILL … HIGH today … Expect the worst … hope for the best!

Positive Indications:

AxoGen (AXGN) closed down-$0.26 to $9.47 with a positive +$0.19 or +2.01% aftermarket indication

Caribou Biosciences (CRBU) closed up +$0.08 to $7.21 with a positive +$0.34 or +4.72% aftermarket indication.

Mesoblast (MESO) closed down-$0.01 to $3.30 with a positive +$0.49 or +14.85 aftermarket indication of resubmittal of BLA to FDA for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)

Ionis Pharmaceuticals (IONS) closed up +$0.63 to $39.87 after Monday’s -$0.78 with a positive +$0.33 or +0.83% aftermarket indication.

 

Maintaining Negative Indication:

BioLife Solutions (BLFS) closed up +$0.32 to $23.44 after Monday’s -$0.38 with a negative -$0.49 or -2.09% aftermarket indication,

 

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

The cell/gene therapy sector acted well in the last session of January, with relative uptrends and minor pullbacks.

I STILL don’t think it’s a good time to add exposure.

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!

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.