November 7, 2022 7:49am
What’s appreciable versus doubtful? This is not a good environment for buying into the sector. Investors should be looking to reduce exposure, by cutting “some” losses on various positions. AGTC already bit the dust, AVRO and VSTM are suffering from de-listing – up-lifts are a bitch with the possibility of reverse stock moves!
News: Intellia Therapeutics (NTLA -$0.19 or -0.37% pre-open) presented additional interim results from an ongoing P1 clinical trial 912 adult patients) of NTLA-2001, an investigational, in vivo CRISPR/Cas9 genome editing therapy in development as a single-dose treatment for transthyretin (ATTR) amyloidosis in collaboration with Regeneron Pharmaceuticals (REGN).
Earnings today: Verve Therapeutics (VERV), Beam Therapeutics (BEAM) - 11/7, bluebird bio (BLUE);
- This week: AxoGen (AXGN) and Sage Therapeutics (SAGE) on Tuesday, 11/8; Ionis Pharmaceuticals (IONS) and Vericel (VCEL) on Wednesday, 11/9
Indications: 2 Positive Indications, 4 Negative Indication Categories, and 1 Pump/Promote
A daily report may say little or a lot and its final judgement may be inconclusive; yet it serves as insurance that all indications are being examined and evaluated.
Why do I keep writing this blog/newsletter to inform investors, what they need to hear that others won’t say or write! Insight is about understanding perception and also about putting into context what is relevant to expectation fulfillment
8:00 a.m. edition
Remember that overnight and pre-open actions in futures don't necessarily translate into actual trading in the coming day’s session.
Dow futures are UP +0.47% or (+152 points), S&P futures are UP +0.44% or (+16 points) and NASDAQ futures are UP +0.39% or (+42 points) early in the pre-open – so far,
U.S. stock futures rose on Monday anticipating a positive open,
European markets are lower,
Asia-Pacific markets were up as exports fell by -0.3% and imports by -0.07%.
Friday, the Dow closed UP +403.55 points (+1.26%), the S&P closed UP +50.68 points (+1.36%) while the Nasdaq closed UP +132.31 points (+1.28%).
Indexes rallied on Friday, but finished the week lower as the latest payroll numbers rise focusing future questionable Fed rate hikes.
“Tuesday is Election Day. The stock market tends to do better with divided government, and Republicans are set to reclaim control of the House and perhaps the Senate. But political forecasters have been predicting at least a House GOP win all year, so it's not clear if Tuesday's actual results will be a big catalyst.” <IBD>
Investors are anticipating Thursday’s CPI report will give further insight into the Fed’s efforts to squash inflation. A hot inflation report could signal to investors that a pivot from higher interest rates, for longer, could be further away than expected.
From the title re NTLA: At both dose levels, NTLA-2001 was generally well tolerated. As previously reported, two of 12 patients reported transient infusion reactions, which were the only observed treatment-related adverse events. One patient in the 0.7 mg/kg dose NYHA Class III cohort experienced a Grade 3 infusion-related reaction, which resolved without clinical sequalae. Per the study protocol, this group was subsequently expanded from three to six patients to further characterize safety at this dose level. No additional patients in the 0.7 mg/kg dose NYHA Class III cohort reported a treatment-related adverse event. No clinically significant laboratory abnormalities were observed at either dose level. Results were presented in a Late-Breaking Science oral presentation at the American Heart Association (AHA) Scientific Sessions 2022.
Economic Data Docket: investors are anticipating Thursday’s CPI report will give further insight into the Federal Reserve’s efforts to squash inflation. A hot inflation report could signal to investors that a pivot from higher interest rates, for longer, could be further away than expected. <CNBC>
Friday’s (11/4) … RegMed Investors’ (RMi) closing bell: “strolling a crooked session (10 of 35 covered companies stumbled” … https://www.regmedinvestors.com/articles/12685
Ebb and flow:
Q4 – November - 4 negative and 1 positive closes
· October -1 neutral, 11 positive and 9 negative closes
· September – 1 holiday, 10 positive and 11 negative closes
· August – 1 neutral, 11 positive and 11 negative closes
· July - 1 holiday, 10 negative and 10 positive closes
Companies in my headlights – It’s your decision; I provide ideas and context: INDICATIONS
Fate Therapeutics (FATE) closed up +$0.39 to $19.84 after Thursday’s -$0.59 and Wednesday’s -$0.95 with a negative -$0.60 or -3.02 pre-open indication
Intellia Therapeutics (NTLA) closed down -$0.67 to $50.94 after Thursday’s +$0.51, Wednesday’s -$2.11, Tuesday’s +$0.43 and last Monday’s -$1.25 with a negative -0.19 or -0.37% pre-open indication
Sage Therapeutics (SAGE) closed down -$1.85 to $34.78 after Thursday’s -$0.27 and Wednesday’s -$0.98 with a negative -$2.34 or -6.73% pre-open indication. SAGE reports earnings of LPS (loss-per-share) on Tuesday 11/8.
Verve Therapeutics (VERV) closed down -$1.03 to $31.29 after Thursday’s -$2.26, Wednesday’s -$1.86, Tuesday’s -$1,26 and last Monday’s -$3.00 with a negative -$7.07 or -22.60% pre-open indication.
BioLife Solutions (BLFS) closed down -$5.93 to $5.93 after Thursday’s +$0.28, Wednesday’s +$0.03, Tuesday’s +$0.49 and last Monday’s +$0.19 with a positive +$1.02 or +5.55% pre-open indication.
Ionis Pharmaceuticals (IONS) closed down -$2.94 to $41.55 after Thursday’s -$0.19 with a positive +$1.71 or +4.19% pre-open indication.
Puff/Pump and Promote: Maintaining SELL
Biostage (OTCQB: BSTG) closed up +$0.01 with 2,953 shares traded after Thursday’s -$0.09 with 800 shares traded, Wednesday’s -$0.05 with 100 shares traded, Tuesday’s flat with 963 shares traded, and last Monday’s -$0.85 with 2,100 shares traded <3-month average = 2,446 shares>
A DRAFT prospectus is filed … SEC Form S-1/A …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 . Questions arise as to draft prospectus statement of non-reliance of past financials? Hey, CFO Joe some of us have copies of lost “payables”?
The BOTTOM LINE: What's changing - nada!
The sector suffered significant damage this past week, with share pricing tumbling.
It doesn’t help that the Russell 2000 hit resistance near the 200-day line but recovered Friday to close above the 50-day line.
t's hard to see a strong sector rally after the week’s session (4 down, 1 up) reeled. Unless … unless the algorithmic “rules” determine there’s room to move – I’m NOT quite there!
Reiterating, “I try to keep it simple … and short …
What changes … “No one company is immune in the sector and this market … of rolling downdrafts?”
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.
Is it a sign of the times for a few gene therapy companies to end-up like AGTC – running out of money with delisting hanging over their head like a sword of Damocles (?) and being forced to be acquired by a shell for a financing or closing down
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:
· AxoGen (AXGN), Voyager Therapeutics (VYGR) and Sage Therapeutics (SAGE) on 11/8,
· Ionis Pharmaceuticals (IONS), Precigen (PGEN) and Vericel (VCEL) on Wednesday, 11/9
While the Fed meeting is like an earnings report for the market rally, don't forget actual earnings.
Investors are still struggling for sector share pricing direction and wanted clarity of guidance in earnings that are to begin in earnest
If you have gains, you might want to lock-in profit (if any) … before earnings season begins!
Reiterating, “Set aside volatility and there still aren't good reasons to be invested now; companies are saving ANY news for the earnings season.”
Investors are still struggling for sector share pricing direction and wanted clarity of guidance in earnings that are to begin in earnest. That means trades that didn't move the market before are now creating more volatility. Sentiment sensitive cell and gene therapy stocks are especially vulnerable.
Legendary investor Jeremy Grantham warns the current market backdrop is among the worst he's ever seen - and says holding cash is a good idea. The veteran investor also confirmed he's betting against the Nasdaq index and high-yield or "junk" bonds, suggesting he expects tech stocks to continue dropping, and corporate defaults to spike. <had an office next door to him, many years ago – a god of markets>
DISPOSE of Avrobio (AVRO) who experiences news and the stock drops after 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 is NOT close to the $1.00 to continue its Nasdaq listing after a delisting notice.
· Where is the upside coming from to “solve” the de-listing “position” on Nasdaq?
· Will AVRO have to “commission" a stock reverse to address its delisting?
· OR, will they “pull” an AGTC?
When it comes time to invest or even hold onto an investment; I’d say … focus on what percentage ownership of stock … NOT options CEOs and management teams own versus their salary and bonus.
Amid the ongoing cell and gene therapy sector volatility, “our” universe’s trend remains " in a constant correction." That means that investors are safer on the sidelines as again … earnings are coming.
My guide to 'good news seems to be bad news' and 'bad news is good news. 'In normal times, no one really questions whether good news in the economy is actually good.
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.
All investments are subject to risks. Investors should consider investment objectives.
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.
Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions securities referred to in this publication.