February 2, 2023 4:44pm
Offering News: Cellectis SA (CLLS) launches a global offering of USD 22 M of its American Depositary Shares, each representing one ordinary share of Cellectis, nominal value €0.05 per share pursuant to an underwriting agreement, with Jefferies LLC and Barclays Capital Inc.
The Biostage (OTCQB: BSTG) Chronicles: Withdrawal of Registration Statement on Form S-1 (File No. 333-265741) - 2/1/23, NO surprise here, the question continues? WHO and WHAT is to pay for a five (5) year ADULT clinical trial/study of a four (4) year old IND?
Pre-open Indications: 3 Hits and 1 Miss
I write this blog/newsletter to inform investors with facts and supporting numbers focused on what they need to hear that others won’t say or write about - truth!
Subscription is coming, it’s not conscription but, an offer to join our collective of like-minded investors! Join me … in the NO spin zone.
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 portfolio are largely tied to your knowledge of price movements and questioning pricing targets.
The Dow closed DOWN -39.02 points (-0.11%), the S&P closed UP +60.55 points (+1.47%) while the Nasdaq closed UP +384.50 points (+3.25%)
Henry’omics:
We need to more than consider the economic environment - rising rates and inflation to comprehend the micro re “our” universe of cell and gene therapy companies
Indexes closed mixed as the Dow fell, the S&P and Nasdaq added value.
The major index was dragged by Merck (MRK) shares after issuing a weak outlook in its latest earnings results, despite beating estimates on the top and bottom lines.
Economic Data Docket: The average rate on the 30-year fixed rate mortgage has fallen to 5.99%, Mortgage News Daily said. The rate started this week at 6.21% and fell sharply Wednesday after the Fed Chair Powell said inflation “has eased somewhat but remains elevated.”
· The next major event on the macroeconomic front is Friday's January jobs report, which will be critical for investors to further assess if there's evidence of an easing labor market.
· Economists, on average, expect the Friday data to show 187,000 jobs were added in January, according to Dow Jones estimates. Though, Thursday afternoon Goldman economists said payrolls could be as high as 300,000, a big number that could mean the Fed has further to go to cool the economy and curb inflation.
Pre-open Indications: 3 Hits <Verve Therapeutics (VERV +$1.94); Sell into Strength: Beam Therapeutics (BEAM +$2.82), Intellia Therapeutics (NTLA +$1.45)> and 1 Miss < BioLife Solutions (BLFS +$1.75)>
Thursday’s … RegMed Investor’s (RMi) Pre-Open: “momentum moved sector with expectation still in no-man’s-land. However, can Thursday replicate its moves; the market often has a day-two reaction to Fed meetings?” … https://www.regmedinvestors.com/articles/12814
RegMed/Stem/Cell and Gene Therapy’s 35 covered equities’ Advance/Decline (A/D) lines: what happened –
- Thursday’s advance/decline line opened positive at 29 up/ 5 down and 1 flat, stayed positive with 29 up/ 6 down and 1 flat at the mid-day, ending with a positive close of 29/5 and 1 flat
Key Metrics:
The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:
- Thursday, the IBB was up +0.34% and the XBI was up +2.44%
The CBOE Volatility Index (VVIX: INDEX) tracked:
- Thursday was up +0.56 points or +3.13% at 18.43
Closing Down (5 of 5):
- Voyager Therapeutics (VYGR -$0.48 after Wednesday’s -$0.08),
- Sage Therapeutics (SAGE -$0.07 after Wednesday’s +$0.32 and Tuesday’s +$1.19),
- Bellicum Pharmaceuticals (BLCM -$0.06),
- Solid Biosciences (SLDB -$0.03 after Wednesday’s -$0.04),
- Compass Therapeutics (CMPX -$0.02 after Wednesday’s -$0.01),
Flat:
- Biostage (OTCQB: BSTG $0.00 after Wednesday’s +$0.28, Tuesday’s -$0.73 and Monday’s -$0.03),
Closing Up (10 of 29):
- Alnylam Pharmaceuticals (ALNY +$4.84 after Wednesday’s -$1.49, Tuesday’s +$1.00 and Monday’s -$5.97),
- CRISPR Therapeutics (CRSP +$3.79 after Wednesday’s +$1.31, Tuesday’s +$1.06 and Monday’s -$2.82),
- Vericel (VCEL +$2.97 after Wednesday’s +$0.90),
- Beam Therapeutics (BEAM +$2.82 after Wednesday’s +$2.32, Tuesday’s +$1.35 and Monday’s -$3.20),
- Prime Medicine (PRME +$2.35),
- Ultragenyx (RARE +$2.10 after Wednesday’s -$0.09, Tuesday’s +$2.34 and Monday’s -$0.74),
- Verve Therapeutics (VERV +$1.94 after Wednesday’s -$0.68, Tuesday’s +$0.98 after Monday’s -$0.65),
- BioLife Solutions (BLFS +$1.75),
- Intellia Therapeutics (NTLA +$1.45 after Wednesday’s +$0.71, Tuesday’s +$2.32 and Monday’s -$1.51),
- Ionis Pharmaceuticals (IONS +$1.17),
Q1/23 – February
- Thursday closed positive with 29 incliner, 5 decliners and 1 flat
- Wednesday (2/1) closed positive with 24 incliner, 10 decliners and 1 flat
The BOTTOM LINE: I try to keep it simple … and short!
A rally is always welcome but, is it investors or algorithms and electronic trading?
The real question will be, WILL the UPSIDE last Friday? I say … NO
Heightened regulatory and commercial risk could/should be hampering gene-editing/ genetic medicine companies focused on rare diseases.
The FDA seems to be applying more regulatory scrutiny to a clinical candidate indicated for broad population segments, potentially extending development timelines with extended patient safety follow-up.
The FDA has not cleared an IND filing for any in vivo gene-editing trial in the U.S. to date.
Upcoming Q4 earnings reporting will present challenges to share pricing.
· Sage Therapeutics (SAGE) 2/16 - Thursday
· Alnylam Pharmaceuticals (ALNY) 2/23 - Thursday
There are VERY clear losers today … Voyager Therapeutics (VYGR), Sage Therapeutics (SAGE) and Chinook Therapeutics (KDNY)
With winners … Beam Therapeutics (BEAM) – again, CRISPR Therapeutics CRSP) and Alnylam Pharmaceuticals (ALNY),
Avrobio (AVRO) closed up +$0.01 to $0.94 with 638,562 shares traded after Wednesday’s +$0.02, Tuesday’s +$0.01, Monday’s +$0.01 with 206,848 shares traded, Friday’s +$0.02 to $0.88 with 144,019 shares traded and last Thursday’s -$0.0206 with 511,978 shares traded <3-month average = 343,693 shares>
The many sessions since acknowledging the de-listing “issue” say a lot of addressing the NASDAQ issue <is their investment bank buying the shares?> as AVRO filed a S-3 for $250 million common stock, preferred stock, debt securities, warrants and unit offering within draft prospectus by Cowen as stock sinks while de-listing continues?
STILL, just another “screw-job” of investors! < Read, SELL and Weep - see hyperlink below>
Avrobio (AVRO) files S-3 (Registration Statement) for offering with draft prospectus by Cowen … https://investors.avrobio.com/node/9116/html
· Also, RA Capital has sold its position in the company – a sign of dissatisfaction!
· While, President, CEO and director Geoff Mackay carries home a HUGE salary of $754.39 K per year?
Biostage (OTCQB: BSTG)
Tuesday closed flat with 0 shares traded after Wednesday’s +$0.28 with 467 shares traded, Tuesday’s -$0.73 with 3,710 shares traded after Monday closed down -$0.03 with772 shares traded, Friday’s flat with 1,695 shares traded after Thursday’s $0.00 with 2,300 shares traded and last Wednesday’s $0.00 with 2,100 shares traded. <3-month average volume = 1,255 shares>
· BSTG has “pulled” its proposed offering … “Withdrawal of Registration Statement on Form S-1 (File No. 333-265741)”
· This IND – now almost 4 years old without a clinical trial that will last 3-5 years for ADULT patients before BSTG can EVEN consider a pediatric venue!
Question; is this a Ponzi scheme (the pump/promote buy and sell agenda) as shares are bought to replace those sold??
My question that resounds, that should be asked is how many companies are at the end of sentiments … leash?
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.