September 10, 2018 6:08pm

It’s a good metaphor which means exploring one session at a time what’s causing the downdraft and it’s more complicated than most can gleam …

The question is, how many sessions does it take to realize appreciation of downtrodden value?

 

Earnings: Applied Genetic Technologies’ (AGTC -$0.15) net loss was $6.6 million or -$0.37 per share Q4/18 and $21.3 million or -$1.18 for the FY ended 6/30/18, compared to net loss of $3.2 million or -$0.18 and net income of $400 K or +0.02 per share in the comparable periods in 2017. A daily report may say little or a lot and its final judgement may be inconclusive; yet it serves as insurance that all indications are being examined and evaluated.

Out and about: Update on U.S Federal Circuit Decision Upholding the Ruling by U.S. PTO in Interference Proceeding Relating to CRISPR/Cas9 Genome Editing Technology - The interference proceeding remains terminated without any determination on inventor ship of CRISPR/Cas9 genome editing application to eukaryotic cells

 

We crave explanations because they give us an illusion of control. Your portfolio should be profiting from RMi’s analysis!

Henry’omics:

Selling pressure has been exacerbated by the concentration of high momentum small-cap biotechnology stocks in exchanges traded funds. Once the sell orders come in from trend followers, these ETFs must sell all the stocks in the basket, regardless of fundamentals or liquidity.

Both the S&P and the NASDAQ are coming off four straight daily declines. Last week was the S&P’s first negative week of the past four, and it represented the biggest weekly percentage drop since June. The NASDAQ suffered its biggest weekly drop since March.

We’re still experiencing declines based on a solid August but, volume is LOW; the main priority for the sector is NEWS while investors look at September’s declines. There’s so much to look for in this new week …

 

From the pre-open newsletter: “: the oversold are demanding retribution. There is constancy to rebalancing especially after extreme ups and downs … I am anticipating a rebound because low volume volatility is a set-up for new heights and add to them when they become cheap.”

 

Of the 45 companies covered on Monday; 28 downside equities finished in a range of -0.32% (RARE) to -12.89% (HSGX) while 17 upside equity oscillated from +0.67% (VSTM) to +9.60% (FIXX) with 2 flat closes (ADVM and RENE.L).

 

Earnings:

Applied Genetic Technologies Corp. (AGTC) on Monday reported a loss of $6.6 million or a loss of $0.37 per share.

The results did not meet “Street” expectations of a loss of $0.23 per share. AGTC posted revenue of $5.4 million in the period.  For the year ‘18, AGTC revenue was reported as $24.2 million.

In the final minutes of trading on Monday, the company's shares hit $4.35. A year ago, they were trading at $4.65. The key word was “INCREASED” (R&D, G&A, tax provision, clinical hiring, net loss as compared to DECREASED revenue (non-refundable upfront fees received under the company’s collaboration with Biogen).

AGTC has three sites open for enrollment with additional sites expected to launch over the next several months. AGTC has enrolled 5 patients and expects to complete the dose escalation portion of the XLRP trial in the first quarter of 2019.

 

Out and about:

CRISPR Therapeutics AG (CRSP -$0.45 or -0.90%), Intellia Therapeutics, Inc. (NTLA -$0.26 or 0.95%) and Caribou Biosciences, Inc. announced that the U.S. Court of Appeals for the Federal Circuit affirmed the decision by the U.S. Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board (“PTAB”) in an interference proceeding relating to CRISPR/Cas9 genome editing technology.

The interference was requested by the Regents of the University of California, the University of Vienna and Dr. Emmanuelle Charpentier (collectively “UC”), co-owners of foundational intellectual property relating to CRISPR/Cas9 genome engineering, against the Broad Institute, Harvard University and the Massachusetts Institute of Technology (collectively “Broad”).

In its decision, the Federal Circuit (Case No. 17-1907) indicated that because it would “not reweigh the evidence,” due to the deferential nature of appellate review, the PTAB had sufficient basis to discontinue the interference “given the mixture of evidence in the record.”

The Federal Circuit, like the PTAB, did not decide whether UC or the Broad actually first invented the CRISPR/Cas9 genome editing technology.

The Federal Circuit opinion also does not preclude other proceedings, either at the USPTO or in the courts, to determine which research group is the actual inventor and, thus, the proper owner of the technology. The court expressly indicated that its decision was limited to “the scope of two sets of applied-for claims and whether those claims are patentable distinct.” The Federal Circuit also emphasized that its decision was “not a ruling on the validity of either set of claims.”

Consistent with the consensus of the scientific community, the companies believe firmly in the strength, breadth and scope of the foundational IP covering the technology developed by Drs. Emmanuelle Charpentier and Jennifer Doudna and their research teams. The companies expect that the USPTO will continue to issue patents to UC covering the foundational CRISPR/Cas9 technology, including its use in any environment. The USPTO recently issued U.S. Patent No. 10,000,772 for the use of CRISPR/Cas9 genome editing covering widely used guide formats in various environments, including eukaryotic cells. The companies expect this is the first of many patents that will issue based on the foundational work done by Drs. Charpentier and Doudna and their teams.

As Editas medicine (EDIT) closed up +$0.82 or +2.71% … “We are pleased with the Federal Circuit’s decision affirming the Patent Trial and Appeal Board decision on the patents that were granted to the Broad Institute for its innovative and fundamental work on CRISPR/Cas9 genome editing,” said Katrine Bosley, President and Chief Executive Officer, Editas Medicine. “This decision is highly favorable for Editas and for the Broad as it reaffirms the strength of our intellectual property foundation and has profound implications for making CRISPR medicines.”

 

Daily analytics and metrics:

  • The Dow closed down -59.47 points or -0.23% to 25,857.07
  • The S&P closed up +5.45 points or +0.19% to 2,877.13
  • The NASDAQ closed up +21.62 points or +0.27% to $7,924.16

 

The advance/decline line scenario of 45 covered companies:   

  • The open was neutral with an A/DL of 22/22 and 1 flat;
  • The mid-day slipped negative with an A/DL of 15/27 and 3 flats;
  • The close was negative with an A/DL of 17/28 and 2 flats;

 

Daily volume anomaly (volume versus 3 month average): 

  • FIXX increased pricing and volume
  • AST decreased pricing an increased volume
  • BLFS decrease pricing and increased volume
  • CRSP decreased pricing and increased volume
  • BLUE decreased pricing and increased volume
  • HSGX decreased pricing and increased volume
  • SGMO increased pricing and increased volume

 

Four (4) key metrics:  

… The greatest volume to the downside: HSGX, BLUE, CRSP, ALNY and BMRN

… Upside volume was weighted to:  SGMO, VSTM, IONS, XON and GBT

… Leadership ($) to the downside:  SAGE (-$7.38) ALNY (-$4.75), BLUE (-$3.55), RGNX (-$1.55) and BLFS (-$1.17)

… Best moves ($) to the upside:  FIXX (+$1.57), SLDB (+$1.02), GBT (+$1.00), SGMO (+$0.90) and EDIT (+$0.82)

 

The iShares NASDAQ Biotechnology (IBB) closed:

  • Monday was up +0.17%
  • Friday was down -0.57%
  • Thursday was down -1.78%
  • Wednesday was down -0.30%
  • Tuesday was down -0.97%
  • Last Monday was a holiday

 

September sessions:

Monday’s closed NEGATIVE with 28 decliners, 17 advancer and 2 flats 

Friday’s closed POSITIVE with 15 decliners, 23 advancer and 7 flats 

Thursday’s closed NEGATIVE with 39 decliners, 1 advancer and 5 flats 

Wednesday’s closed NEGATIVE with 30 decliners, 12 advancers and 3 flats 

Tuesday’s (9/4) closed NEGATIVE with 22 decliners, 19 advancers and 4 flats  

 

 

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.