RegMed Investors’ (RMi) closing bell: the sector stays up

April 2, 2019 8:09pm

I had recommended selling into strength

Sorry late in publishing, while I was consciously decoupling from my favorite Volvo after an engine fire, luckily getting-out unharmed; should I have been cautious of SELL calls as the sector is on fire?

Pre-open indications: 8 HITs and 1 MISS

News: Fate Therapeutics (FATE +$0.85) presented pre-clinical data highlighting the FATE’s unmatched ability to mass produce uniformly engineered chimeric antigen receptor (CAR) T cells for off-the-shelf cancer immunotherapy. BioLife Solutions (BLFS +$0.27) closed the previously announced transaction for the acquisition of Astero Bio , an innovator in the design, development and commercialization of novel automated thawing devices for cell and gene therapies, for an upfront cash payment of $8 M.

You’d be reading if you were a subscriber!

Duty, honor and shareholders should be a mantra – it’s mine!

Markets and indexes:

• The Dow closed down -79.29 points or -0.30% to 26,179.13
• The S&P closed flat at 2,867.24
• The NASDAQ was up +19.78 points or +0.25% to 7,848.69

Henry’omics:

Sector equities closed up after some negative tones at the open yet, perked up at the 10 a.m.

However, gains will be harder to come by moving forward.

I had recommended … SELLING into strengths to start protecting against ANY downside – and I was RIGHT.

I am NOT optimistic about the short-term share pricing future unless positive news flow picks-up

Data released Tuesday showed capital goods orders fell 0.1% in February, while economists polled by Refinitiv expected an unchanged print.

My own personal safety came close to ending as my car (Volvo) caught fire (under the hood) and burned down to the tires. I got out be falling to my side for it (the fire) seemed to come from nowhere, I had just come from the Registry of Motor Vehicles (RMV) arriving at Costco – thank you to the Waltham, Ma fire dept. and police!

Cell and gene therapy company’s worst-performers were: 

• Tuesday's: RENE.L (-$1.50), QURE (-$0.40), STML (-0.12), VCEL (-$0.12) and MDXG (-$0.10)
• Monday's: ALNY (-$1.62), SAGE (-$1.20), BOLD (-$1.19), BLFS (-$0.28) and CRSP (-$0.27)

\Sector equities posting gains were:

• Tuesday's: SGMO (+$2.76), RARE (+$2.63), SAGE (+$2.48), CRSP (+$2.45) and BLUE (+$1.82)
• Monday's: RENE.L (+$22.00), MDXG (+$0.20), MESO (+$0.28), FIXX (+$1.41) and STML (+$0.55)

Pre-open post, “after some good gains, there is always a slip and pain ensues. Remember, “when one feels the pain, you know you’re not dead yet” … Trade, my point is to pass on warning analysis or Intel so no dollar is left on the table but, in your portfolio!”

My pre-open indications: 8 HITs and 1 MISS

• bluebird bio (BLUE) closed up +$1.82 – miss;
• Biostage (BSTG) closed down -$0.02 – hit;
• CRISPR Therapeutics (CRSP) closed up +$2.47 – hit;
• Editas Medicine (EDIT) closed up +$1.31 – hit;
• Intellia Therapeutics (NTLA) closed up +$0.84 – hit;
• MiMedx Group (MDXG) closed down -$0.10 – hit;
• ReNeuron Group (RENE.L) closed down -$1.50 – hit;
• Sangamo Therapeutics (SGMO) closed up +$2.76 – hit;
• Verastem Oncology (VSTM) closed up +$0.08 – hit;

The advance/decline line scenario of 45 covered companies:  

• The open was negative with the A/DL to 17/22, 5 flats and 1 acquired (AST);
• The 10 a.m. hour turned positive with an A/DL of 27/16 and 1 flat and 1 acquired;
• The close was positive with an A/DL of 32/11 and 1 flat and 1 acquired;

Tonight’s percentage (%) indicators: 

• Range of the 32 upside was +0.52% (HSGX) to +28.96% (SGMO) while the 11 downside ranged from -0.17% (KOOL) to -1.20% (RENE.L).

Volume stats: 

• 8 out of the 32 upside had higher (than the 3 month average) volume
• 4 out of the 11 downside experienced greater volume (than the 3 month average)

1 flat – ONCE with 1 acquired: 1 (AST)

The iShares NASDAQ Biotechnology (IBB) indicator:

• Tuesday was up +0.81 %;
• Monday was up +0.10 %;
• Friday was up +2.14 %;
• Thursday was up +0.61%;
• Wednesday was down -1.39%;
• Last Tuesday was up +1.86%;

News:

Fate Therapeutics (FATE) presented preclinical data highlighting the Company’s unmatched ability to mass produce uniformly engineered chimeric antigen receptor (CAR) T cells for off-the-shelf cancer immunotherapy at the American Association of Cancer Research (AACR) Annual Meeting 2019 in Atlanta, Georgia (LB-073/18: Generation of Novel Single Cell-derived Engineered Master Pluripotent Cell Line as a Renewable Source for Off-the-shelf TCR-less CAR T Cells in support of First-of-kind Clinical Trial).

FATE’s proprietary approach to CAR T-cell therapy utilizes a one-time genetic modification event followed by high-throughput selection of a single gene-edited induced pluripotent stem cell (iPSC). In contrast to repeatedly engineering large populations of patient- or donor-derived T cells which results in batch-to-batch and cell-to-cell variability, the Company has shown that a single gene-edited iPSC can be maintained as a clonal master engineered iPSC line which can be repeatedly used for production of uniformly engineered CAR T cells.

“The efficiency, accuracy, and uniformity of genetic modifications have the potential to impact the safety and efficacy of CAR T-cell therapy. We know that, when engineering a population of T cells, current gene-editing technologies create genomic heterogeneity and result in undesired byproducts, such as DNA mutagenesis and translocations. The selection of a single gene-edited cell for the derivation of a clonal master engineered iPSC line ensures that the effects of gene editing can be fully characterized and that only engineered T cells meeting rigorous quality standards are administered to patients,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics.

New preclinical data presented today at AACR for FT819, the Company’s universal, off-the-shelf CAR19 T-cell product candidate being developed under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., demonstrate the production of clonal master engineered iPSC lines having complete elimination of T-cell receptor (TCR) expression and insertion of a novel 1XX CAR signaling domain into the T-cell receptor alpha (TRAC) locus. These synthetic features are intended to mitigate the risk of graft-versus-host disease, a severe life-threatening condition that occurs when donor T cells attack a patient’s healthy tissue, and to regulate CAR expression to enhance the therapeutic profile of CAR T cells.

April sessions:

Tuesday closed POSITIVE with 11 decliners, 32 advancers, 1 flat and 1 acquired (AST);

Monday (4/1) closed POSITIVE with 19 decliners, 23 advancers, 2 flats and 1 acquired (AST);

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.

Whether information or intelligence is good, bad or somewhere in between; I put into context what is relevant and useful for investors.  All investments are subject to risks. Investors should consider investment objectives.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.