RegMed Investors’ (RMi) closing bell, another sector flip-flop

July 31, 2017 5:23pm

Opens down, stays down at mid-day and closes to the downside

As the NASDAQ dives, some news sputters, two down sessions; even I thought we’d see an upside movement session

Reiterating, daily to-and-fro action has a downward tilt contributing to the more investor uncertainty as Q2 financial results kick-off …

Pre-open indications: 7 hits and 3 miss

Out and about: Organovo (ONVO – closed flat) and UC San Diego Receive $1.7 M grant from NIH to Study Liver Disease; Kite Pharma (KITE – closed down) filed the Industry’s First CAR-T Marketing Authorization Application in the EU for Axicabtagene Ciloleucel, Spark Therapeutics (ONCE – closed down) submitted a marketing authorization application to European Medicines Agency for Investigational LUXTURNA(TM) (voretigene neparvovec) and uniQure (QURE – closed down) reacquires development and commercialization rights for its Gene Therapy Candidate in Hemophilia B

The value of news is suspect

It’s called premium content for a reason … I define insight  from a real-time perspective discussing equity share pricing, attractiveness and support levels as stock pricing changes by the hour … if not the minute!

Others don’t even come close!

I answer one question, in which company should investors commit and keep their money.

Monday’s results have implications to Tuesday’s sector activity as a daily report may say little or a lot and it serves as insurance that all indications are being examined and evaluated!

Henry’omics:

From the pre-open’s investor’s newsletter, “Cell therapy is a roll of the dice sector. And a dice games leaves the fate of it players completely and utterly up to chance. Good things could come but, how long can we wait and how much more can we lose in share pricing.”

• Technical backdrop for stocks shows investors should be cautious as volume was still LOW while the sector slipped again; which seems higher in selling – again; it is just a gauge of sentiment.

The cell therapy sector is entering the usual weak seasonal period side-by-side with investor pessimistic views of quarterly financial results. Historically, the period from August through October has seen stocks struggle and a period when corrections have tended to occur more than often,

• Reiterating, “What needs to change, the value of staying the course is an overworked belief in this world of high-frequency trading, ETF exposure and the summer doldrums.  Admittedly, every cell therapy investing group is more focused on the short term as the average holding period has shrunk from years, months to days or hours — the rewards of patience are declining by the minute.”

The advance/decline line scenario of 43 SCGT & RT covered companies:   

·         The first hour was negative with an A/DL of 4/35 and 4 flats;

·         The mid-day was negative with an A/DL of 9/32 and 2 flats;

·         The close was negative  with an A/DL of 9/31 and 3 flats;

Pre-open indications:  7 hits and 3 miss

• Applied Genetic Technologies (AGTC) closed up +$0.05 – hit;
• BioLife Solutions (BLFS) closed down -$0.05 – miss;
• Biostage (BSTG) closed down -$0.0032 – hit;
• Capricor (CAPR) closed down -$0.08 – hit;
• Cellectis SA (CLLS) closed down -$0.97 – miss;
• Cesca Therapeutics (KOOL) closed down -$0.13 – hit;
• Juno Therapeutics (JUNO closed down -$0.35 – hit;
• Kite Pharma (KITE) closed down -$3.02 – miss;
• Neuralstem (CUR) closed down -$0.11 – hit;
• Vericel (VCEL) closed down -$0.05 – hit;

Out and about:

Organovo Holdings, Inc. (ONVO) has received a three-year, $1.7 million grant from the NIH to collaboratively study non-alcoholic fatty liver disease (“NAFLD”) with researchers at University of California San Diego School of Medicine.  Grant payments will be spread over three years as research milestones are successfully completed. 

·         Deteriorating liver function is a growing and serious public health concern, with an estimated 100 million adults in the U.S. afflicted with NAFLD, while up to 20 million more Americans are projected to have non-alcoholic steatohepatitis (“NASH”).  Left unchecked, these diseases can progress to cirrhosis and cancer, with NASH being the second leading cause of liver transplants in the U.S.  Despite decades of intense research worldwide, the understanding of NAFLD progression and the development of novel therapeutic approaches have been limited by the lack of advanced systems that mimic human liver biology over an extended period of time.

·         “Traditional preclinical models often fall short in their ability to inform clinical outcomes accurately, largely due to the limited functionality of simple in vitro models and species differences, said Dr. Sharon Presnell, CSO of ONVO.

Kite Pharma (KITE) filed the industry’s first CAR-T Marketing Authorization Application in Europe for Axicabtagene Ciloleucel

·         KITE submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who is ineligible for autologous stem cell transplant. This application represents the first chimeric antigen receptor (CAR) T-cell therapy submitted to the EMA. Axicabtagene ciloleucel is currently under review by the U.S. FDA, and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 29, 2017.

·         The MAA for axicabtagene ciloleucel is supported by data from the ZUMA-1 trial, which met the primary endpoint of objective response rate (ORR), with 82 percent (p < 0.0001) of patients achieving a response after a single infusion of axicabtagene ciloleucel. At a median follow-up of 8.7 months, 44 percent of patients were in ongoing response, which included 39 percent of patients in complete response (CR). The most common Grade 3 or higher adverse events included cytokine release syndrome and neurologic events, which were generally reversible.

uniQure (QURE) reacquires development and commercialization Rights for its Gene Therapy Candidate in Hemophilia B

·         QURE has entered into an agreement with Chiesi Group to reacquire the rights to co-develop and commercialize its hemophilia B gene therapy in Europe and other select territories and to terminate their co-development and license agreement.

Spark Therapeutics Submits Marketing Authorization Application to European Medicines Agency for Investigational LUXTURNA(TM) (voretigene neparvovec)

·         ONCE submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for LUXTURNA(TM), the proposed trade name for voretigene neparvovec, an investigational, one-time gene therapy for the treatment of patients with vision loss due to Leber congenital amaurosis or retinitis pigmentosa caused by confirmed biallelic RPE65 mutations. The MAA includes data from three clinical trials that enrolled 41 participants with RPE65-mediated inherited retinal dystrophy (IRD), including the first randomized, and controlled P3 trial for a gene therapy for a genetic disease.

·         Once EMA has validated the application, the review period will begin. Spark Therapeutics has previously received orphan product designations for LUXTURNA from EMA for the treatment of both Leber congenital amaurosis and retinitis pigmentosa.

·         The investigational therapy is under Priority Review with the U.S. Food and Drug Administration, with an assigned Prescription Drug User Fee Act (PDUFA) date of Jan. 12, 2018.

Daily analytics:

The Dow closed at a record on Monday, but weakness pressured the NASDAQ and limited the S&P 500's advance.

The Dow rose 61 points, or 0.3%, to 21,891. The S&P 500 slipped 1.7 point to 2,470, a decline of less than 0.1%. The NASDAQ fell 0.4%, or 26.5 points, to 6,348. Despite the tepid moves on the day, all three (3) closed out July with strong monthly gains.

The Dow gained 2.6% over the month while the S&P was up 2%; both have risen for four (4) straight months. The NASDAQ rose 3.4% over July. All three (3) indexes have risen in eight (8) of the past nine (9) months.

The CBOE Volatility Index (VIX) widely considered the best gauge of fear in the market, traded Monday at 10.30 up +0.10% …

·         Friday at 10.29 up +1.78 following Thursday’s +5.31% to 10.11, Wednesday’s 9.60, Tuesday’s near 9.43 – flat as compared to last Monday’s 9.43 …

Welcome to another day of the sector’s roller coaster …

… The iShares Russell 2000 (IWM) indicated:

·         Monday down -0.31%

·         Friday down -0.28%

·         Thursday was down -0.64%

·         Wednesday was down -0.57%

·         Tuesday was up +0.89%

·         Last Monday’s up +0.14%

… The iShares NASDAQ Biotechnology (IBB) indicated:

·         Monday down -0.85%

·         Friday up +0.63%

·         Thursday was down -1.87%

·         Wednesday was up +0.65%

·         Tuesday was down -1.08%

·         Last Monday’s up +0.76%

The count - decliners versus gainers:

……. look at the differences in the spreads as decliners jump and %’s migrate…

·         Monday’s decliners ranged from -0.03% <IMUC> to -8.16% <FCSC> in 31 equities;

·         Friday’s decliners ranged from -0.02% <CYTX> to -12,31% <CAPR> in 25 equities;

·         Thursday’s decliners ranged from -0.45% <OPXA> to -29.15% <CUR> in 31 equities;

·         Wednesday’s decliners ranged from -0.30% <XON> to -12.10% <CUR> in 18 equities;

·         Tuesday’s decliners ranged from -0.10% <JUNO> to -49.64% <CUR> in 29 equities;

·         Last Monday’s decliners ranged from -0.35% <BSTG> to -56.77% <CYTX> in 18 equities

Versus

………… look at the percentage’s (%) and their decreases …….

·         Monday’s gainers ranged from +0.49%  <VTGN> to +4.64% <AXGN> in 9 equities;

·         Friday’s gainers ranged from +0.27%  <XON> to +11.92% <KOOL> in 16 equities;

·         Thursday’s gainers ranged from +0.28%  <FCSC> to +28.71% <CAPR> in 10 equities;

·         Wednesday’s gainers ranged from +0.28%  <VSTM> to +18.85% <ISCO> in 21 equities;

·         Tuesday’s gainers ranged from +0.56%  <XON> to +2.16% <NWBO> in 10 equities;

·         Last Monday’s gainers ranged from +0.61%  <ATHX> to +10.22% <NWBO> in 20 equities;

Some of MY working trend lines or indications:

… The greatest volume to the downside:  NWBO, ATHX, CYTX, JUNO and IMUC

… Upside volume was weighted to:  MDXG, VSTM, AXGN, AST and FATE

… Biggest $ downside:  ATHX, CAPR, QURE, MESO and RENE.L

… Largest $ upside:  AXGN, MDXG, OSIR, FATE and ISCO

… Flat: PSTI, ADVM and ONVO

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.