November 14, 2022 4:54pm

Indication Results: 4 Hits, 2 Miss and 1 Pump/Promote

News: Agenus (AGEN +$0.42) announced its expanded data from P1 study of botensilimab (Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients with treatment-resistant tumors, including MSS-CRC, ovarian, sarcoma and NSCLC. This expanded dataset demonstrates the tremendous potential of botensilimab and balstilimab to treat a wide range of immunotherapy-resistant tumors,” said Steven O’Day, M.D., CMO of AGEN. I stated weeks ago, AGEN would “blossom”!

Earnings: Brainstorm Cell Therapeutics (BCLI +$0.12) had a Q3 net loss of -$6.9 million or -$0.19 per share with a cash position of $7.4 million (with $20 million loan) and a Q1/2024 runway.

News: Beam Therapeutics (BEAM -$1.19) the first patient has been enrolled in the company’s BEACON trial. BEACON is an open-label, single-arm, multicenter, P1/2 clinical trial designed to evaluate the safety and efficacy of BEAM-101 in adult patients with severe sickle cell disease (SCD). The 1st clinical trial of a base editor in the U.S.

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 DOWN -211.16 points (-0.63%), the S&P closed DOWN -35.60 points (-0.89%) while the Nasdaq closed DOWN -127.11 points (-1.12%)



The Dow, S&P and the Nasdaq fell; trading was choppy throughout the day, with the market struggling for direction throughout the session.

I like the quote, “The mood of investors is cautiously optimistic,” Sylvia Jablonski, CEO and chief investment officer of Defiance ETFs, told CNBC. “The general sentiment I’m hearing out there is that traders are more likely to expect a sustainable run from this point on — maybe it won’t be the face ripper that we hope for but sustainable upside — through the end of the year before we hit 2023 and you start to really see what the Fed hikes have done to the economy and how fragile our earnings are.”

Volume on the Nasdaq was significantly lower when compared to the same time on Friday.

News (continued) Agenus (AGEN): The data presented represents four of the most mature data sets from the nine cancer types where responses have been observed to date. The superior efficacy we observed in our MSS-CRC presentation at GI ESMO earlier this year has remained consistent across a larger dataset. Further, we are seeing a strong signal with higher response rates than has been reported with other immunotherapies in multiple tumor types, including anti-PD-(L)1 relapsed/refractory NSCLC. These data provide compelling support for our ongoing Phase 2 botensilimab development program and highlight the broad therapeutic potential of botensilimab across solid tumors.” <The data was presented at a plenary session at the Society for Immunotherapy of Cancer (SITC) annual meeting and a company-hosted R&D event.>



Monday’s … RegMed Investor’s (RMi) Pre-Open: “after an upside ending week. What’s next … I still believe many cell and gene therapy equities are overbought” …


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 18 up/ 7 down and 1o flat, stayed negative with 12 up/ 23 down and 0 flat at the mid-day, ending with a negative close of 13/21 and 1 flat.


Pre-open Indications: 4 Hit < Ultragenyx Pharmaceuticals (RARE -$1.30), Vericel (VCEL -$0.71), CRISPR Therapeutics (CRSP -$0.57), BioLife Solutions (BLFS -$1.85)> 2 Miss <Avrobio (AVRO +$0.03), bluebird bio (BLUE +$0.15)> 1 Pump/Promote < Biostage (OTCQB: BSTG +$0.71),


Key Metrics:

  • Monday - Sector volume was MODERATE with 5 of the 13-upside having higher than the 3-month average volume with HIGHER volume of 10 of 21-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 up +0.32% and the XBI was down -0.81%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Monday was up +1.21. points or +5.37% at 23.73


Jumping with share pricing momentum (13 of 13):

  • Agenus (AGEN +$0.42),
  • Biostage (OTCQB: BSTG +$0.71),
  • Ionis Pharmaceuticals (IONS +$0.79 after Friday’s -$2.22),
  • Sage Therapeutics (SAGE +$0.35),
  • Compass Therapeutics (CMPX +$0.24),
  • Chinook Therapeutics (KDNY +$0.24 after Friday’s -$0.75),
  • bluebird bio (BLUE +$0.15),
  • Brainstorm Cell Therapeutics (BCLI +$0.12 after Friday’s -$1.22),
  • Homology Medicine (FIXX +$0.10),
  • Precigen (PGEN +$0.05),
  • Avrobio (AVRO +$0.03),
  • Voyager Therapeutics (VYGR +$0.03),
  • Solid Biosciences (SLDB +$0.03),

Closing down (10 of 21):

  • Alnylam Pharmaceuticals (ALNY -$2.89 after Friday’s +$3.92),
  • BioLife Solutions (BLFS -$1.85),
  • Intellia Therapeutics (NTLA -$1.65 after Friday’s +$2.20),
  • Prime therapeutics (PRME -$1.51 after Friday’s +$0.55)
  • Ultragenyx (RARE -$1.30 after Friday’s -$1.57),
  • Beam Therapeutics (BEAM -$1.19 after Friday’s +$6.77),
  • Fate Therapeutics (FATE -$0.80 after Friday’s +$1.99),
  • AxoGen (AXGN -$0.76 after Friday’s -$0.29),
  • Vericel (VCEL -$0.71 after Friday’s +$1.39),
  • Verve Therapeutics (VERV -$0.65 after Friday’s +$3.62),

Flat (1)

  • MiMedx (MDXG),


Q4 – November

  • Monday closed negative with 13 incliner, 21 decliners and 1 flat


The BOTTOM LINE: Earnings season is STILL going on …

The wind blows where it will as algorithms are BACK …driving the sector …  this time down after Friday and Thursday’s upside spirals.

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.”

The story continues, “Faze Medicines, a neuroscience-focused startup that spun out of Third Rock Ventures in late 2020, is winding down. Clovis Oncology, a maker of cancer drugs, will likely file for bankruptcy protection due to dwindling sales of its sole product, mounting financial losses, and a crushing debt load.”

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”!

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

·         Biostage (OTCQB: BSTG), Tuesday, 11/15

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

Avrobio (AVRO) experiences news as the stock flops bac-and-forth 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 +$0.03 after Friday’s +$0.066 which STILL does NOT get close to the $1.00 to continue its Nasdaq listing after a delisting notice.

·         AVRO’s 55th session of under $1.00,

·         Will AVRO have to “commission" an offering to relieve the delisting?

Avrobio (AVRO) files S-3 (Registration Statement) for offering with draft prospectus by Cowen …

•             A SCREW-JOB for early and present investors ...

Isn’t this Verastem Oncology’s (VSTM closed down -$0.02 after Friday’s +$0.01 …

Isn’t it VSTM’s 37th 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.