October 31, 2022 4:57pm

Pre-open indications: 4 Hit and 2 Miss

The Biostage (OTCQB: BSTG closed -$0.85 with 2,050 shares traded) Chronicles: SEC Form S-1/A filed Prospectus for unit offering …https://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=117017206&type=HTML&formType=S-1%2FA&dateFiled=2022-10-27&cik=0001563665&CK=1563665&symbol=0001563665&companyName=Biostage ; A lot of issues in DRAFT prospectus - reliance on past financials, I have some "lost" copies the CFO should want?

It’s an honor to be considered the “canary in the (sector) coal mine”!  I post about “indication intelligence” devoting my time to collection and analysis of information to assist investors in the perception of sector vulnerabilities and strengths

It’s more than opinion, the facts and truth need to be recognized! Why do I keep writing this blog/newsletter; to inform investors, what others won’t say or write

If I have learned one thing as a former research analyst in a venture and public fund now a journalist; it is that your life and your bank account are largely tied to your knowledge of price movements and questioning pricing targets.


The Dow closed DOWN -128.85 points (-0.39%), the S&P closed DOWN -29.08 points (-0.75%) while the Nasdaq closed DOWN -114.31 points (-1.03 %)



Indexes slipped Monday as the final trading day of October kicked off, but the major averages snapped a two-month losing streak.

From the title section: Alnylam Pharmaceuticals (ALNY) - said last week that it was holding off on a planned P3 pivotal study for vutrisiran in Stargardt disease (the drug is already marketed as Amvuttra in its sole approved indication so far, hATTR amyloidosis with polyneuropathy). The announcement illustrates how the Inflation Reduction Act is already having a negative impact on small molecule and orphan drug R&D prioritization, but nevertheless brought out skeptics of the biotech industry, who argue the new law is being scapegoated by innovators who want to overturn its Medicare drug-’negotiation’ provisions. <RA Capital>

Economic Data Docket: The Chicago purchasing managers’ index, a measure of economic health in the manufacturing sector in the Midwest, fell unexpectedly in October. The index for the month slipped to 45.2, down from 45.7 a month earlier. That fell below the consensus estimate of 47. It’s now at its lowest level since May 2020, when it fell to 32.2.


RegMed Investor’s (RMi) Pre-Open: “final session of October. A week of earnings LPS (loss-per=share) starts the month.” … https://www.regmedinvestors.com/articles/12675


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

  • Monday’s advance/decline line opened negative at 7 up/ 25 down and 3 flats,  flipped barely positive with 16 up/15 down and 4 flats at the mid-day, ending with a negative close of 13/22 and 0 flat.


Pre-open Indications: 4 Hit < Solid Biosciences (SLDB +$0.30), Sage Therapeutics (SAGE -$0.56), Beam Therapeutics (BEAM -$4.68), Biostage (OTCQB: BSTG -$0.85)> 2 Miss < Agenus (AGEN -$0.04), Intellia Therapeutics (NTLA -$1.25)>


Key Metrics:

  • Monday - Sector volume was LOW with 3 of the 13-upside having higher than the 3-month average volume with LOW volume of 2 of 22-downside having higher than the 3-month average volume

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

  • Monday, the IBB was down -0.84% and the XBI was down -1.92%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +0.11 points or +0.43% at 25.84


Jumping with share pricing momentum (13 of 13):

  • Solid Biosciences (SLDB +$0.30 after Friday’s -$0.70 after reverse split),
  • Vericel (VCEL +$0.53),
  • Alnylam Pharmaceuticals (ALNY +$2.75 after Friday’s +$10.51),
  • AxoGen (AXGN +$0.26 after Friday’s -$0.04),
  • BioLife Solutions (BLFS +$0.19 after Friday’s +$1.65),
  • Prime Therapeutics (PRME +$0.17 after Friday’s +$1.35),
  • Brainstorm Cell Therapeutics (BCLI +$0.15 after Friday’s -$0.03),
  • bluebird bio (BLUE +$0.03),
  • Bellicum Pharmaceuticals (BLCM +$0.03),
  • Mesoblast (MESO +$0.02 after Friday’s -$0.07),
  • Verastem (VSTM +$0.015),
  • Precigen (PGEN +$0.01),
  • Avrobio (AVRO +$0.004),

Closing down (10 of 22):

  • Beam Therapeutics (BEAM -$4.68 after Friday’s +$2.43),
  • Verve Therapeutics (VERV -$3.00 after Friday’s +$4.73),
  • CRISP Therapeutics (CRSP -$1.95 after Friday’s +$1.93),
  • Intellia Therapeutics (NTLA -$1.25 after Friday’s +$1.87),
  • Fate Therapeutics (FATE -$0.88 after Friday’s +$1.15),
  • Biostage (BSTG -$0.85 after Friday’s -$0.20),
  • Sage Therapeutics (FATE -$0.56),
  • uniQure NV (QURE -$0.42),
  • Ionis Pharmaceuticals (IONS -$0.41),
  • Ultragenyx (RARE -$0.30 after Friday’s +$1.43),


Q4 - October - it's over

Friday closed negative with 13 incliner,22 decliners and 0 flat

Friday closed positive with 28 incliner, 6 decliners and 1 flat

Thursday closed negative with 4 incliner, 30 decliners and 1 flat

Wednesday closed positive with 23 incliner, 12 decliners and 0 flat

Tuesday closed positive with 28 incliner, 5 decliners and 2 flats

Monday closed negative with 9 incliner, 26 decliners and 0 flat

Friday closed positive with 27 incliner, 4 decliners and 4 flats

Thursday closed negative with 15 incliner, 19 decliners and 1 flat

Wednesday closed negative with 1 incliner, 34 decliners and 1 flat

Tuesday closed positive with 21 incliner, 13 decliners and 1 flat

Monday closed positive with 33 incliner, 2 decliners and 1 flat

Friday closed negative with 5 incliner, 30 decliners and 1 flat

Thursday closed positive with 25 incliner, 9 decliners and 1 flat

Wednesday closed positive with 19 incliner, 15 decliners and 1 flat

Tuesday closed neutral with 17 incliner, 17 decliners and 1 acquired

Monday closed negative with 4 incliner, 30 decliners and 1 acquired

Friday closed negative with 8 incliner, 25 decliners and 1 flat and 1 acquired

Thursday closed positive with 21 incliner, 11 decliners and 3 flats

Wednesday closed negative with 12 incliner, 22 decliners and 1 flat

Tuesday closed positive with 30 incliner, 5 decliners and 0 flat

Monday closed positive with 19 incliner, 15 decliners and 1 flat


The BOTTOM LINE:  I try to keep it simple … and short!

Kenny Storch at BTIG, states there are 226 public biotech companies trading below cash currently. With 1 out of 5 in the Nasdaq Biotech Index trading below cash. <I have also been stating the same theme!>

We will be seeing what October brings – Q3 earnings LPS (loss-per-share) season and a whole lot of economic indicators.

Q4 is HERE and we are back into Q3 earnings season which could be a minefield:

·         Mesoblast (MESO - today

·         MiMedx (MDXG), Ultragenyx (RARE) and Editas Medicine (EDIT) on 11/2 at 5 p.m.

·         Fate Therapeutics (FATE), Cellectis SA (CLLS), Sangamo Therapeutics (SGMO) and Regenxbio (RGNX) on Thursday, 11/3,

·         AxoGen (AXGN) and Sage Therapeutics (SAGE) on 11/8,

·         Ionis Pharmaceuticals (IONS) and Vericel (VCEL) on Wednesday, 11/9

If you have gains, you might want to lock-in profit if any … as earnings season begins!

DISPOSE Avrobio (AVRO) who experiences news (completion of dosing) on Thursday and Tuesday as the stock drops following a de-listing notice while the management DID NOTHING to AVOID this dilemma while president, CEO and director Geoff Mackay carries home a HUGE salary of $754.39 K per year?

·         AVRO closed up a barely up +$0.004 to $0.68 which STILL does NOT get close to the $1.00 to continue its Nasdaq listing after a delisting notice.

·         AVRO’s 46th session of under $1.00,

·         Will AVRO have to “commission" a stock reverse to address delisting?

·         Or, will they “pull” an AGTC and get acquired by a shell?

Isn’t this Verastem Oncology’s (VSTM +$0.01 to $0.41); its 27th session of being UNDER $1.00 heading for de-listing under Nasdaq

October has 1 neutral, 11 positive and 9 negative closes;

As I continually question, “The real question that should be asked is how many companies are at the end of sentiments …  leash?

I stick to my view of anticipating the risks – as my careers focus has been “warning analysis”.


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.

Regulation Analyst Certification (Reg AC): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.