December 7, 2020 7:48am

At the moment, consider ASH presentations and any sector highs and bottoms

Pre-open indications: 7 BUY and 2 SELLs

Weekend News: Global Blood Therapeutics (GBT), Cellectis SA (CLLS), bluebird bio (BLUE) and Monday News:  Mesoblast ((MESO) and Sangamo Therapeutics (SGMO)

What I provide is an “intelligence daily” to ensure that shareholders are kept apprised based on a 24-hour surveillance of “our” universe, the RegMed/cell and gene therapy sector and its surrounding markets

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Dow futures are DOWN -0.36% (-110 points), S&P futures are DOWN -0.36% (-14 point) and NASDAQ futures are DOWN -0.08% (- 10 points)

 

U.S. stock futures are falling Monday after a Friday’s record-setting session;

European stocks traded lower as the U.K. and EU attempt yet another “reach” to close a post-Brexit trade deal as the pan-European Stoxx 600 index traded -0.5% lower;

Asia-Pacific markets traded mixed as shares in Japan, Hong Kong and the Chinese mainland struggled for gains yet, Australia rose.

 

Data Docket: a relatively normal week for economic reports, featuring small business optimism, Michigan consumer sentiment, and jobless claims data. Little is expected from the CPI and PPI data. The JOLTS report remains a lagging indicator for overall economic strength.

 

Henry’omics:

Monday’s implied an opening loss …

Last week, COVID-19 hospitalizations and single-day deaths reached new peaks in the U.S., the S&P 500 and Nasdaq both closed at record highs

Also, last week’s gains came even after the release of disappointing U.S. jobs data.

However, lawmakers have been in a standoff over additional fiscal aid for months, raising concern about the economic recovery from the coronavirus pandemic.

My weekly word of intelligence … CAUTION.

 

An Update: RegMed/Cell and Gene Therapy Earnings Scorecard Q3/20 LPS Results https://www.regmedinvestors.com/articles/11628     

 

Monday news: Pfizer (PFE) and Sangamo Therapeutics (SGMO) announce updated P1/2 results showing sustained Factor VIII activity Levels in 3x1013 VG/KG cohort through one year following Hemophilia A Gene Therapy.

  • All five patients in the high dose 3 x 1013 vg/kg cohort have had at least one year of follow-up and showed sustained factor VIII (FVIII) activity levels, with a group median FVIII activity of 56.9% and a group geometric mean FVIII activity of 70.4% via chromogenic assay from week 9 to 52. Steady-state FVIII activity was achieved for all patients in the 3 x 1013 vg/kg cohort within 9 weeks of treatment with giroctocogene fitelparvovec, with no bleeding events and no FVIII infusions (beyond 3 weeks post-infusion) within the first year. As of the cutoff date of August 31, 2020, one patient had one target joint bleed requiring FVIII therapy, occurring after week 52.

 

Monday news: Mesoblast (MESO; ASX: MSB) announced results which provided in vivo biomarker evidence linking remestemcel-L’s immunomodulatory activity to survival outcomes in children with steroid-refractory acute graft versus host disease (SR-aGVHD). I.E., clinically meaningful overall responses and survival in children with SR-aGVHD treated with remestemcel-L were associated with significant reductions in certain biomarkers of inflammation which have been validated as predictors of mortality risk

 

Sunday news: Global Blood Therapeutics (GBT) announced new preclinical data on its sickle cell disease (SCD) pipeline therapies – inclacumab, a novel P-selectin inhibitor in development to reduce the frequency of vaso-occlusive crises (VOCs) in patients with SCD, and GBT021601, a next-generation hemoglobin S (HbS) polymerization inhibitor.

 

Saturday news: Cellectis SA (CLLS) announced preliminary results from its dose escalation P1 BALLI-01 study of UCART22 product candidate in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) were presented at the American Society of Hematology (ASH) Annual Meeting. This is the first publicly released data from Cellectis’ BALLI-01 clinical trial.

  • The anti-leukemia activity observed in these patients with B-ALL who had been previously heavily pre-treated speaks to the validity of CD22 as a target in the CAR T-cell space, and demonstrates the promise of allogeneic cellular therapies to leapfrog the autologous CAR-T products.

 

Saturday news: CRISPR Therapeutics (CRSP) and Vertex (VRTX) announced new data on a total of 10 patients treated with the investigational CRISPR/Cas9-based gene-editing therapy, CTX001.

  • That show a consistent and sustained response to treatment. All seven patients with transfusion-dependent beta thalassemia (TDT), including three who have either a severe or b0/b0 genotype, were transfusion independent at last follow-up and all three patients with sickle cell disease (SCD) were free of vaso-occlusive crises (VOCs) from CTX001 infusion through last follow-up.

 

Late Friday news: Fate Therapeutics (FATE) announced positive interim data from the dose escalation P1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma.

  • FT516 is a universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

 

 

Friday’s night’s recap: RegMed Investors’ (RMi) closing bell: “shake it off as markets shook-off a disappointing U.S. jobs report hoping it will arouse fiscal stimulus measures” … https://www.regmedinvestors.com/articles/11664

  • The Nasdaq closed UP +87.05 points (+0.70%);
  • The IBB closed up +0.93% and XBI closed up +1.85%
  • Sector volume was LOW with 9 of the 25-upside having higher than the 3-month average volume with the increased volume of 3 of 9-downside having higher than the 3-month average volume;
  • The CBOE Volatility Index (VVIX: INDEX) was down -0.49 points or -2.30% at 20.79;
  • Friday’s percentage (%) of the 25-upside were +0.09% (BLUE) to +7.48% (KDNY) while the 9-downside ranges from -0.14% (GBT) to -4.90% (MDXG);

Q4:

  • Q4’s December, so far: 1 neutral and 3 positive closes
  • Q4’s November: 16 positive and 3 negative closes
  • Q4’s October: 1 neutral, 11 positives with 1 negative closes
  • Q3: July through September: 1 neutral, 28 positive and 34 negative closes with 2 holidays

 

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

Maintaining Sell:

Biostage (BSTG) closed up =$0.07 to $1.42 with 3,514 shares traded after Thursday’s -$0.00 to $1.35 with 2,418 shares traded, Wednesday’s -$0.01 to $1.36 with 8,574 shares traded, Tuesday’s +$0.01 to $1.36 with 902 shares traded and last Monday’s -$0.01 to $1.35 with 1,575 shares traded;

  • Question#1: WHO is running this company into the ground of sentiment, perception and ranking?
  • Question#2: WHAT is the short, near and long-term objective of this technology platform?

 

Maintaining SELL into Strength:

BioLife Solutions (BLFS) closed up +$2.35 to $38.89 after Thursday’s +$1.44 to $36.54, Wednesday’s $35.10, Tuesday’s $34.99, Monday’s $35.99 and last Friday’s $35.91 with NO aftermarket indication;

Fate Therapeutics (FATE) closed down -$0.11 to $60.42 after Wednesday’s +$0.31 to $60.53, Tuesday’s +$1.76 to $60.22, Monday’s +$0.55 to $58.47 and last Friday’s $57.92, A 52-week change of +346.06% and a short percentage (%) of float of -22.79%, There’s “room” to profit with a POSITIVE +$8.21 or +13.51% aftermarket indication;

Cellectis SA (CLLS) closed up +$0.24 to $29.44 after Thursday’s $29.20, Wednesday’s $26.58, Tuesday’s $26.84 and last Monday’s $25.37 with weekend news and NO aftermarket indication. On 11/2, the share price was $15.87 with a 52-week change of 97.72;

CRISPR Therapeutics (CRSP) closed up +$7.08 to $147.54 after Thursday’s +$8.92, Wednesday’s +$1.96, Tuesday’s +$2.66 and last Monday’s +$5.37). A 52-week change of +118.74%, share pricing high of $151.11 and a low of $32.20;

Editas Medicine (EDIT) closed up +$1.26 to $34.49 after Thursday’s +$1.67, Wednesday’s-$0.34, Tuesday’s +$1.31 and last Monday’s -$0.75) with a NEGATIVE -$0.14 or -0.41% aftermarket indication;

Sage Therapeutics (SAGE) closed up +$1.89 after Thursday’s +$1.29, Wednesday’s +$4.07, Tuesday’s -$1.45 and last Monday’s -$1.48 with a NEGATIVE -$0.05 or -0.07% aftermarket indication;

Maintaining BUY:

Applied Genetic Technologies (AGTC) closed up =$0.02 to 44.69 after Thursday’s -$0.33 to $4.67, Wednesday’s +$0.18 to $5.00, Tuesday’s $4.82, Monday’s $4.44 and last Friday’s $4.34 with NO aftermarket indication but … a sincere belief that it is OVERSOLD;

Global Blood Therapeutics (GBT) closed down -$0.05 to $43.85 after Thursday’s -$0.88 to $43.90, after Wednesday’s -$3.40 to $44.78, Tuesday’s +$2.27 to $48.18, Monday’s +$1.01 to $45.91. GBT announced (Sunday) new preclinical data on its sickle cell disease (SCD) pipeline therapies – inclacumab, a novel P-selectin inhibitor in development to reduce the frequency of vaso-occlusive crises (VOCs) in patients with SCD, and GBT021601, a next-generation hemoglobin S (HbS) polymerization inhibitor.  

 

The BOTTOM LINE: Sector equities were polished like an apple on Friday as markets shook off disappointing numbers on job creation in November.

Lockdown restrictions in response to the third wave of the pandemic are a  subliminal weight on this market.

There are just too many … BUTS, HOWEVERS and POSSIBILITIES of EXPECTATION in this market.

 

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.