May 24, 2021 5:52pm

Earnings: Biostage (BSTG) reports Q1/21, net loss of 900K, or -$0.09 per share with subsistence cash position of $500 K and a runway until Q2/21 also NO mention of year-old IND and ANY clinical trial

Pre-open indication performance: 9 HITs and 1 MISS

Big winner today: Verastem VSTM +$0.77 on news of grant of the coveted “Breakthrough Therapy Designation” (BTD) for their experimental cancer-combo therapy.

If you’re looking for sector intel, ideas and facts or numbers (which don’t lie) in a volatile climate, RMi defines the rigors of share pricing! My comments distinguish the temporary from real pricing digression or progress.

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The Dow closed UP +183.14 points (+0.54%); the S&P closed UP +41’19 points (+0.99%) while the Nasdaq closed UP +190.18 points (+1.41%)

 

Henry’omics:

Indexes climbed on Monday …

Momentum based on buying the dips however did not make the message loud-enough for “our universe’ to hear.

Although I “felt” this was going to be a weak Monday for the cell and gene therapy sector with a secondary title of “ready, aim, don’t fire” but dropped it!

 

From this a.m.’s news: Verastem granted the coveted Breakthrough Therapy Designation (BTD) for VSTM's experimental cancer-combo therapy.

  • Verastem (VSTM - the U.S. FDA granted Breakthrough Therapy designation for the combination of its investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.
  • RAS is the most frequently mutated oncogene, occurring in 30% of human cancers.1,2 These cancers are typically highly aggressive and recurrent, sending signaling commands through the RAS pathway. VS-6766 is a novel dual inhibitor of the RAF/MEK signaling pathway. With this unique dual mechanism of action, VS-6766 confers vertical inhibition of the RAS pathway in a single drug. Verastem Oncology is evaluating VS-6766 in combination with agents targeting other nodes in the RAS pathway as well as with agents targeting parallel pathways to address multiple cancer indications and mutations.

 

RegMed Investors’ (RMi) pre-open: “heading into the last full trading week of the month” …  https://www.regmedinvestors.com/articles/11924

 

RegMed/Stem/Cell and Gene therapy’s 35 covered equities’ Advance/Decline (A/D) lines:

  • Monday opened positive at 17/15, 2 flat and 1 acquired, flipped negative by the mid-day to 8/25, 1 flat and 1 acquired, closing negative at 9/23, 2 flats and 1 acquired;

 

Pre-open indication results:  9 HITs < BUY: Verastem (VSTM +$0.79); Maintain SELL: Biostage (BSTG +$0.00 at $1.30 with 45 shares traded); bluebird bio (BLUE -$0.95), Regenxbio (RGNX -$0.80), uniQure NV (QURE -$0.22); SELL, take some profit: Editas Medicine (EDIT -$0.02), Intellia Therapeutics (NTLA +$3.52), CRISPR Therapeutics (CRSP +$0.03), Sage Therapeutics (SAGE -$3.00) > and 1 MISS < Chinook Therapeutics (KDNY +$0.04),

 

RegMed/Cell and Gene Therapy Earnings Scorecard Q1/21 LPS Results … to date: https://www.regmedinvestors.com/articles/11628

 

There are clear winners and losers

Jumping with share pricing momentum:

  • Verastem (VSTM), Intellia therapeutics (NTLA), MiMedx (MDXG), AxoGen (AXGN), Bellicum Pharmaceuticals (BLCM), Fate Therapeutics (FATE), Chinook therapeutics (KDNY), Vericel (VCEL), CRISPR Therapeutics (CRSP), to name 9 of the 9 inclining of the 35 covered

Hammered in today’s market:

  • Sage Therapeutics (SAGE), Ultragenyx (RARE), Alnylam Pharmaceuticals (ALNY), ReNeuron (RENE.L), BioLife Solutions (BLFS)to name 5 of the 23 declining of the 35 covered

 

Key metrics:

  • Sector volume was LOW with 2 of the 9-upside having higher than the 3-month average volume with the volume of 2 of 23-downside having higher than the 3-month average volume;
  • Monday’s percentage (%) of the 9-upside were +0.03% (CRSP) to +24.76% (VSTM) while the 23-downside ranges from -0.06% (EDIT) to -4.69% (AGTC);

 

Monday’s (9 of 9) incliners:

  • Intellia Therapeutics (NTLA +$3.52);
  • Verastem (VSTM +$0.77);
  • AxoGen (AXGN +$0.27);
  • MiMedx (MDXG +$0.22);
  • Fate Therapeutics (FATE +$0.22);
  • Vericel (VCEL +$0.11);
  • Chinook Therapeutics (KDNY +$0.04);
  • CRISPR Therapeutics (CRSP +$0.03);
  • Bellicum Pharmaceuticals (BLCM +$0.02);

Monday’s (10 of 23) decliners:

  • Applied Genetic Technologies (AGTC -$0.200;
  • Sage Therapeutics (SAGE -$3.00);
  • Precigen (PGEN -$0.26);
  • Voyager Therapeutics (VYGR -$0.15);
  • BioLife Solutions (BLFS -$1.14);
  • bluebird bio (BLUE -$0.95);
  • Solid Biosciences (SLDB -$0.12);
  • Pluristem (PSTI -$0.11);
  • Homology Medicine (FIXX -$0.16);
  • Brainstorm Cell Therapeutics (BCLI -$0.09);

Closing 2 – Athersys (ATHX), Biostage (BSTG) and 1 - Stemline Therapeutics (STML – acquired)

 

COVID-19 updates:

  • The U.S. is reporting an average of fewer than 30,000 new Covid cases per day for the first time since June of last year.

Wednesday’s COVID Data Tracker <Million>:

  • Cases: 32.9 M
  • Death rate totaled 587,342 - dipping <Johns Hopkins University>
  • Vaccinations (at least one):  61.5%

 

Stats:

The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:

  • Monday, the IBB closed down -0.61% and XBI closed down -0.66%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was down -1.75 points or -8.68% at 18.40

Upside volume: low

  • Monday: 2 out of the 9-upside had higher than the 3-month average volume;

Downside volume: low

  • Monday: 2 out of the 23-downside had higher than the 3-month average volume;

Percentage (%) movement/range statistics: LOW % with limited pricing drops as upside maintains

  • Monday’s percentage (%) of the 9-upside were +0.03% (CRSP) to +24.76% (VSTM) while the 23-downside ranges from -0.06% (EDIT) to -4.69% (AGTC);

 

May, second month of Q2/21:

Monday (5/24) closed negative with 9 advancers, 23 decliners, 2 flat and 1 acquired

Friday closed positive with 14 advancers, 18 decliners, 2 flats and 1 acquired

 

The BOTTOM LINE: As I had stated on Friday, “Expect the sector rotation trades to continue to play out.”

And it did again on Monday, choppy/sideways trend will continue, and the sector will experience … more sell-off scares along the way.

Q1 earnings season is wrapping up and my reaction to earnings LPS (loss-per-share) results reveals more than some skepticism that Q1 losses provide a reason for additional forward-looking less than optimistic and more pessimism through the mid-year.”

I’m STILL a “beware or the cautious man” whose focus has always been “warning analysis” … earnings’ season is NOT over … my advice, trim and skim any new highs if one can!”

My time frame of measurement remains Friday to Friday and has been proved right again, don’t get complacent …

 

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.