August 3, 2022 7:50am

Earnings today: AxoGen (AXGN), Editas Medicine (EDIT), Fate Therapeutics (FATE), MiMedx (MDXG) and Vericel (VCEL)

The Biostage (BSTG) Chronicles: its BOD approved on 7/28 amending and restating their Certificate of Incorporation to affect a reverse split of the issued and outstanding common stock at a ratio of not less than 1-for-1.25 and not greater than 1-for-5. What about all those PPM (private placements) as an offering follows?

News: Alnylam Pharmaceuticals (ALNY +$61.92), the APOLLO-B P3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, met the primary endpoint of change from baseline in the 6-Minute Walk Test (6-MWT) at 12 months compared to placebo (p-value 0.0162). The study also met the first secondary endpoint of change from baseline in quality of life compared to placebo, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) (p-value 0.0397).

Pre-open indications: 3 Negative Indications, 8 Positive Indications, 1 Sell into Strength and 1 Puff/Pump/Promote

RMi outlines a daily bell ringing of “indications” about what you need to know; it’s what could happen or materialize after the opening and what might happen during the session.

I DEVOTE a HUGE amount of time to “reckoning” the geography of my coverage group - it’s more than opinion, I deal in the facts and numbers that back them up.

The 8:00 A.M., ET 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 +0.48% or (+154 points), S&P futures are UP +0.52% (+21 points) and NASDAQ futures are UP +0.53% (+68 points) early in the pre-open – so far,


U.S. stock futures traded higher Wednesday,

European stocks were mixed,

Asia-Pacific were mostly higher as mainland China indexes gave up early gains and turned negative.



Indexes retreated Tuesday amid House Speaker Nancy Pelosi's trip to Taiwan and hawkish Fed comments. The Dow closed DOWN -401.64 points (-1.22%); the S&P closed DOWN -27.32 points (-0.66%) while the Nasdaq closed DOWN 20.22 points (-0.16%).

An appropriate quote, “today’s attention is still riveted on the Federal Reserve and its ongoing fight to bring inflation under control, many economic policies have already embarked on a new easing cycle,” said The Leuthold Group’s Jim Paulsen. “The prospect of lower inflation is not only helping to usher in a new easing cycle but is apt to stoke a private-sector confidence revival that has untapped potential.”

Earnings’ Update: MiMedx (MDXG) reported a net loss of -$10.9 M or -$0.11 with $72.5 M in cash and a runway until 2024

Economic Data Docket: mortgage demand numbers and PMI data


RegMed Investors’ (RMi) closing bell: “indexes are mixed as cell and therapy sector responds to being oversold with electronic trading”

Ebb and flow –

Q3/22 – August – 1 positive and 1 negative close

July -1 holiday, 10 negative and 10 positive closes

Q2/22 –

June – 1 holiday, 9 positive and 11 negative closes

·         May - 11 positive and 10 negative closes

·         April - 1 holiday, 6 positive and 13 negative closes


·         March – 13 negative and 10 positive closes

·         February stats: 11 negative, 8 positive closes and 1 holiday

·         January stats: 2 holidays, 1 neutral, 13 negative and 6 positive closes


Companies in my headlights – It’s your decision; I provide ideas and context: INDICATIONS

Expectation from those companies’ releasing earnings today:

The shots-in-the dark …

·         AxoGen (AXGN) – aftermarket +$0.18 or 1.75%

·         Editas Medicine (EDIT) – aftermarket +$0.42 or +2.55%

·         Fate Therapeutics (FATE) – aftermarket -$0.12 or -0.39%

·         MiMedx (MDXG) – aftermarket +$0.31 or +9.01%

·         Vericel (VCEL) - none

Negative indications;

·         Regenxbio (RGNX) -$0.43 or -1.35

Positive Indications:

·         Alnylam Pharmaceuticals (ALNY) +$61.92 or +43.61% (news in title)

·         CRISPR Therapeutics (CRSP) +$1.53 or +2%

·         Intellia Therapeutics (NTLA) +$7.96 or +12.43%

·         uniQure NV (QURE) +$0.54 or +2.24%

Sell into Strength:

Verve Therapeutics (VERV) closed up +$1.04 to $23.64 after Monday’s -$2.02 after Friday’s -$2.93 with a positive +$0.35 or +1.48% pre-open indication,

Positive Indications:

Caribou Biosciences (CRBU) closed down -$0.01 to $8.01 after Monday’s-$0.10 <52-week low of $4.89> with a positive +$0.22 or +2.75% pre-open indication,


Puff/Pump and Promote: Maintaining SELL

Biostage (OTCQB: BSTG) closed flat again with 0 shares after Monday’s flat traded 0 flats after Friday’s $0.00 with 0 shares traded, Thursday’s up +$0.50 with 600 shares traded and last Wednesday’s -$0.05 with 545 shares traded <3 mo. Average = 1,206 shares>

·         BSTG seems to have the ONLY avenue to finance to utilize non-U.S. Chinese investors?

·         How much lipstick is a lot on this pig with an almost 4-year-old IND and NO clinical trial initiation?

·         WATCH and be ready for a BIG reverse of shares to enable offering from multiple private placements as it tries to facilitate an offering with Newbridge Securities


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

Earnings season ramps-up this week …

Sector equity pricing are trending in a roller coaster fashion. Also, expectations are really low; we are up, down, up and down – it gets tiring!

We always need a … villain and they are multiplying – low volume as “Earnings’ season is here and now, investors NEED to focus on LPS (loss-per-share), trial status, product revenues, collaboration revenues and cash positions i.e., runways”.

This week: Agenus (AGEN) and Intellia Therapeutics (NTLA) and Sangamo Therapeutics (SGMO) on 8/4; Precigen (PGEN) and Global Blood Therapeutics (GBT) on 8/8 followed by Agenus (AGEN), BioLife Solutions (BLFS) and Ionis Pharmaceuticals (IONS) on 8/9, Brainstorm Cell Therapeutics on 8/15, Monday … to date.

As I have written, “It’s STILL nice to be RIGHT” about the direction of the sector having “DEVOTED a HUGE amount of time to “reckoning” the geography of my coverage group.”

Whether information or intelligence is good, bad or somewhere in between; RMi’s daily report is a primer that may say little or a lot; yet it serves as insurance that all indications are being examined and evaluated.


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.