RegMed Investors’ (RMi) pre-open: the roller-coaster keeps rolling

June 30, 2020 7:41am

In this environment, share pricing is unfathomable although the volatile month and quarter are about to end

Pre-open indications: 4 BUYs and 3 SELLs

News: Vericel (VCEL) and MediWound (private) submitted a Biologics License Application (BLA) to the FDA seeking the approval of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

What I provide is an intelligence daily. Where are the canaries in the sector coal mine, am I the only one?  Subscription is coming, it’s not conscription but, an offer to join our collective of like-minded investors who make money and for those who read and don’t weep!

Can you afford NOT to read it? Check the Bottom line …

Dow futures are DOWN -0.06% (-15 points), S&P futures are DOWN -0.02% (-1 points) and NASDAQ futures are DOWN -0.01% (-1 points)

U.S. stock futures were dipping on Tuesday on the final trading day of a volatile month for markets;

European stocks were mixed over concerns of the coronavirus balanced on investor sentiment, despite promising data out of China as the pan-European Stoxx 600 hung at the flatline;

Asia Pacific stocks as China’s official manufacturing Purchasing Manager’s Index for June came in above expectations; also, the MSCI Asia ex-Japan index rose 0.62%.

Data docket: The holiday-shortened week ahead brings pending home sales Monday and …

• S&P/Case-Shiller home prices Tuesday;
• The Conference Board’s consumer confidence index will be released at 10 a.m. Economists polled are expecting a read of 91 in June, up from May’s reading of 86.6;
• Fed chair Powell and Treasury Secretary Mnuchin will testify before the House Financial Services Committee at 12:30 p.m. on Tuesday. The joint hearing will address the Fed and Treasury’s response to the coronavirus pandemic.
• China’s official manufacturing PMI for June came in at 50.9, according to data released by the country’s National Bureau of Statistics (NBS). Economists in a Reuters poll had a median forecast of 50.4 for the data print. PMI readings above 50 signify expansion, while those below that indicate contraction. In May, the official manufacturing PMI was at 50.6, according to the NBS;
• However, data from Japan Tuesday showed that industrial production in May dropped 8.4% month on month, according to data released in a preliminary report by the country’s Ministry of Economy, Trade and Industry.

Henry’omics:

While rising coronavirus cases have worried investors, stocks are on pace to end June in positive territory. The Dow has risen 0.8% this month and the S&P 500 is up 0.3%, while the Nasdaq has surged more than 4%. <MarketWatch>

We are sequestered in a “conviction-less” market in a most uncertain period with the greatest number of unknowns …

I’d rather be a flat stock equity, than a “splat”!

News (continued): Vericel (VCEL) and MediWound:

• The BLA submission for NexoBrid is based on multiple preclinical and clinical studies including the pivotal P3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns up to 30% of total body surface area. 
• The study met its primary endpoint of complete eschar removal as well as all secondary endpoints, including shorter time to eschar removal, a lower incidence of surgical eschar removal, and lower blood loss during eschar removal compared to standard of care (SOC), including both surgical and non-surgical debridement methods. 
• A key safety endpoint, non-inferiority in time to complete wound closure compared with patients treated with SOC, was also achieved.  Long-term follow-up data to assess cosmesis, function, and quality of life, including 12-month results from the DETECT study, were also included in the submission.
• NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic in the United States, European Union and other international markets. 
• VCEL holds an exclusive license for North American commercial rights to NexoBrid.  Funding and technical support to MediWound Ltd. for development of NexoBrid is provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

Monday’s night post’s title: “sector open positive, slowly weakening as the session closed. US coronavirus statistics worsened over the weekend but traders ultimately washed-out the negativity.”

• The NASDAQ closed UP +116.93 points (+1.20%);
• Monday opened positive and closed negative;
• The IBB closed down -0.36% and XBI also closed down -0.02%
• Sector volume was LOW with 5 out of the 10-upside having higher than the 3-month average volume and 4 out of the 23-downside having higher than the 3-month average volume;
• Monday’s percentage (%) of the 10-upside were +0.46% (SGMO) to +9.18% (ADVM) while the 23-downside ranged from -0.14% (SAGE) to -12.40% (BCLI); 

Q2:

• June registered 11 positive and 10 negative closes
• May registered 9 negative, 11 positive closes and 1 holiday.
• April registered 10 negative, 11 positive closes and 1 holiday.

Q1:

• March registered 11 negative, 10 positive closes and 1 neutral close.
• February registered 9 negative, 9 positive closes, 3 vacation days and 1 holiday.
• January registered 9 negative, 10 positive closes and 2 holidays.

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

Maintaining SELL:

Biostage (BSTG) closed flat at $2.51 after Friday’s -$0.01 and Thursday’s -$0.29 and has more issues that will affect the stock which only moves with day trading as approximately 92% of the millions of private shares just added 3 million to managements personal pockets i.e. “employee benefit plan security offering” – RUN. By the BYE, how many executives and employees; are left – 6 and 1 consultant? Let’s not forget a desperate need for financing?

Maintaining BUY

uniQure NV (QURE) closed down -$0.75 to $45.73 after Friday’s -$2.74 and Thursday’s -$13.69 to $49.22 on I thought a CSL Behring licensing deal of cash ($450 million) upfront and royalty stream (potential $2 billion) and has a positive +$0.40 or +0.81%. QURE will still be responsible for taking the therapy through a P3 trial.

ReNeuron (RENE.L) closed up +$7.50 after being flat on Friday RENE.L reflects a pre-market indication or +$3.00 or +2.08% on news of further positive long-term data from the ongoing P2a clinical trial of its hRPC stem cell therapy candidate in retinitis pigmentosa (RP).  RP is a group of hereditary diseases of the eye that lead to progressive loss of sight and ultimately blindness;

Mesoblast (MESO) closed down -$0.30 to $10.91 after Friday’s -$0.35 to $11.21 and has a positive +$0.29 or +2.66% aftermarket indication;

Regenxbio (RGNX) closed down -$1.13 to $36.96 and has a positive +0.16 or +0.44% aftermarket indication

SELL after an up Monday session:

CRISPR Therapeutics (CRSPP closed up +$1.01 to $75.05 after Friday’s -$2.01 to $74.04 and has a negative -$4.05 or -5.40% aftermarket indication;

Editas Medicine (EDIT) closed up +$0.42 to $29.34 after Friday’s -$2.49 and has a negative -$0.31 or -1.06% aftermarket indication;

The BOTTOM LINE: As I had stated on Monday, “Remember, the Phoenix regenerates and rises from the ashes of its predecessor (maybe not today <Meaning Monday> but, be ready) and wear a mask to enjoy the “dance” of reversal returns.”

From the title, what does a Phoenix symbolize? It represents transformation, death, and rebirth in its fire. As a powerful spiritual totem, the phoenix is the ultimate symbol of strength and renewal.

Also, the Phoenix “dies” in setting each night only to be reborn in rising the next morning.

Let’s hope for the new session to end the month and quarter on a better and high note!

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.