November 8, 2022 4:48pm

Indication Results: 4 Hits and 2 Miss

News: Ionis Pharmaceuticals (IONS +$0.64) announced that GSK presented positive end of study data from the P2b B-Clear study of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense oligonucleotide treatment for patients with chronic hepatitis B virus (CHB). <see below rest>

Earnings: Sage Therapeutics (SAGE) had a Q3 net loss of -$137.2 million or -$2.31 per share with a cash position of $1.5 billion and a 2025 runway. Avrobio (AVRO) had a Q3 net loss of -$23 million or -$0.52 per share with a cash position of $116 million and a 2023 runway. Agenus (AGEN) had a Q3 net loss of -$56.7 million or -$0.19 per share with a cash position of $218 million and a 2024 runway. AxoGen (AXGN) had a Q3 net loss of -$4.3 million or -$0.10 per share with a cash position of $59.4 million and a 2024 runway. Voyager Therapeutics (VYGR) had a Q3 net loss of -$17.6 million or -$0.45 per share with a cash position of $131.6 million and a 2024 runway. Caribou Biosciences (CRBU) had a Q3 net loss of -$26.6 million or -$0.44 per share with a cash position of $342.6 million and a 2025 runway.

It’s an honor to be considered the “canary in the (sector) coal mine”! 

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 UP +335.28 points (+1.02%), the S&P closed UP +21.51 points (+0.57%) while the Nasdaq closed UP +51.68 points (+0.49%)



Indexes rose Tuesday as investors awaited the results of the U.S. midterm elections, which could affect future levels of government spending and regulation.

Market participants are expecting Republicans to take back the House of Representatives and possibly win the Senate as well when results start rolling in Tuesday night.

“A surprise Democratic win in the House and Senate would likely weigh on equities, as market participants might expect additional corporate tax increases.” <Goldman Sachs’ Jan Hatzius>.

Research shows the stock market tends to rally after the midterm election. Since 1950, the average one-year return on the S&P 500 following a midterm was about 15%. <IBD>

From Title, Ionis Pharmaceuticals (IONS) continued:  The results showed that treatment with bepirovirsen resulted in sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA for 24 weeks after end of bepirovirsen treatment in people with CHB. The study results were presented at the American Association for the Study of Liver Diseases' (AASLD) The Liver Meeting® in Washington, DC.

Economic Data Docket: Thursday’s consumer price index report will give further insight into how far the Federal Reserve needs to go to bring down inflation.

  • The most-closely tracked inflation number is forecast to rise 0.7%, higher than September's 0.4%, for an annualized rate of 8%. Core CPI, excluding food and energy, is expected to rise 0.5%, slightly less than September's 0.6%. This would yield an annualized rate of 6.6%.


Tuesday’s … RegMed Investor’s (RMi) Pre-Open: “vote your conscious and your portfolio. Bring-it; as earnings LPS (loss-per-share) releases continue to frame the sector; any market or even sector reaction will likely hinge on whether Republicans take back the House of Representatives, the Senate or both.”


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

  • Tuesday’s advance/decline line opened negative at 16 up/ 17 down and 3 flats, flipped positive with 21 up/ 13 down and 1 flat at the mid-day, ending with a positive close of 22/12 and 1 flat.
  • Monday’s advance/decline line opened negative at 13 up/ 21 down and 1 flat, stayed negative with 12 up/ 23 down and 0 flat at the mid-day, ending with a negative close of 10/24 and 1 flat.


Pre-open Indications: 4 Hit < Avrobio (AVRO +$0.00), Biostage (OTCQB: BSTG $0.00), uniQure NV (QURE +$0.37), Ionis Pharmaceuticals (IONS +$0.64)> 2 Miss <bluebird bio (BLUE +$0.56), Fate Therapeutics (FATE -$0.07), >


Key Metrics:

  • Tuesday - Sector volume was LOW with 12 of the 22-upside having higher than the 3-month average volume with LOW volume of 5 of 12-downside having higher than the 3-month average volume

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

  • Tuesday, the IBB was up +0.98% and the XBI was up +0.94%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was up +1.08 points or +4.44% at 25.33


Jumping with share pricing momentum (10 of 22):

  • Prime Therapeutics (PRME +$1.41 after Monday’s -$2.07),
  • AxoGen (AXGN +$1.38),
  • BioLife Solutions (BLFS +$1.17 after Monday’s +$0.79),
  • CRISP Therapeutics (CRSP +$1.03 after Monday’s -$1.48),
  • Intellia Therapeutics (NTLA +$1.00 after Monday’s -$2.41),
  • Ionis Pharmaceuticals (IONS +$0.64 after Monday’s +$0.06),
  • bluebird bio (BLUE +$0.56 after Monday’s +$0.68),
  • Beam Therapeutics (BEAM +$0.48 after Monday’s -$4.89),
  • Voyager Therapeutics (VYGR +$0.46),
  • Compass Therapeutics (CMPX +$0.39 after Monday’s +$0.01),

Flat (1):

  • Biostage (BSTG)

Closing down (12 of 12):

  • Vericel (VCEL -$1.01 after Monday’s -$0.90),
  • Verve Therapeutics (VERV -$1.17 after Monday’s -$9.54),
  • Ultragenyx (RARE -$0.33),
  • Alnylam Pharmaceuticals (ALNY -$0.17 after Monday’s -$3.41),
  • Agenus (AGEN -$0.16),
  • Brainstorm Cell Therapeutics (BCLI -$0.14),
  • Fate Therapeutics (FATE -$0.07),
  • Mesoblast (MESO -$0.06),
  • Adverum Biotechnologies (ADVM -$0.0453),
  • Homology Medicine (FIXX -$0.04),
  • Regenxbio (RGNX -$0.03 after Monday’s +$0.11),
  • MiMedx (MDXG -$0.01 after Monday’s +$0.10),


Q4 – November

  • Tuesday closed positive with 22 incliner, 12 decliners and 1 flat
  • Monday closed negative with 10 incliner, 24 decliners and 1 flat


The BOTTOM LINE: Algorithms are driving the sector during the midterms election process and session.

Volume was up on the Nasdaq; this is a positive on an up day although the Russell 2000 down -0.5%.

 I try to keep it simple … and short!

I keep repeating a “mantra” for effect, “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!>

Reiterating from the a.m. post: “Is it a sign of the times for a few gene therapy companies to end-up like RUBY (Rubius Therapeutics – seeking “strategic alternatives”, AGTC – running out of money – getting acquired by shell, AVRO and VSTM with delisting hanging over their head like a sword of Damocles (?) or BEAM (Beam Therapeutics (dropping trial) or even Verve Therapeutics (VERV) getting IND halted by FDA.”

WHO or WHICH are NEXT …?

CEO salaries, spending the G&A are totally OUT-OF-WHACK; these are companies are in the development stage and will be for years without products in most cases not like the tech companies, whose CEOs and management teams think they should be compared to for bi-weekly cash and “beanies”!

We will continue seeing what November brings – Q3 earnings LPS (loss-per-share) season, an election and a whole lot of economic indicators.

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

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

·         Brainstorm Cell Therapeutics (BCLI) on Monday, 11/14

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

DISPOSE Avrobio (AVRO) who experiences news (completion of dosing) 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 barely up +$0.0061 to $0.65 after Monday’s +$0.0079 and Friday’s -$0.02 to $0.65 which STILL does NOT get close to the $1.00 to continue its Nasdaq listing after a delisting notice.

·         AVRO’s 517h 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 is up again +$0.0107 to $0.409 after Monday’s +$0.0010 to $0.39 after Friday’s -$0.0088); its 33th session of being UNDER $1.00 heading for de-listing under Nasdaq.

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.