August 5, 2025 4:32pm

Look at herd of earnings and well, most follow the same with ... net losses <although 3 net incomes out of 12 so far>, they all define their clinical momentum yet, cash positions and those with collaboration revenue stand-out. The cell and gene therapy sector can’t manipulate their runways <i.e., need for capital> and timing is important. Earnings are usually predictable; but investors need to focus on post release performance without …  worrying <too much> about follow-on sessions, months and Qs.

Earnings today: Beam Therapeutics (BEAM) and AxoGen (AXGN) <see The Bottom Line>

While the present and future value of RegMed Investors (RMi) earnings sheds light on the cell and gene therapy sector’s “current” acrobatics

Never leave an investor uninformed!  

My perspective is retail investors should roll-the-dice with econ readings as earnings season kicks-in and momentum wains in the cell and gene therapy sector. NO all ins as historically “our” universe slips and slides as the “season’ resumes; so, hang-in with those with solid partners, lengthened runways and solid cash positions leveraged by solid/stable management teams!

 

Tuesday’s RegMed Investors’ (RMi) pre-open: Think about it … https://www.regmedinvestors.com/articles/14048

Monday’s RegMed Investors’ (RMi) pre-open: Yippie yi yo kayah … https://www.regmedinvestors.com/articles/14047

RegMed Investors (RMi) Research Note: Sustaining a Loser … https://www.regmedinvestors.com/articles/13812

 

Tuesday: The Dow closed DOWN -61.90 points or -0.14%, the S&P closed DOWN -30.77 points or -0.49% while the Nasdaq closed DOWN -137.03 points or -0.65%

  • Theme of the session, weak economic data after the ISM Services index flatlined and more tariff threats

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

  • Weaker-than-expected economic data. ISM Services index flatlined in July and indicated higher inflation and lower employment. Services makes up about 70% of the U.S. economy, so a slowdown in the sector could mean trouble ahead.
  • The ISM services index was at 50.1 for the month, representing the percentage of companies seeing expansion. Anything below 50 indicates contraction, a level the gauge has not seen since May 2020. Economists had been looking for a reading of 51.2 after June’s 50.8.
  • Within the survey, the prices index rose 2.4 points to 69.9 while new export orders fell 3.2 points to 47.9 and imports tumbled 5.8 points to 45.9. At the same time, the employment index slipped further into contraction territory, down 0.8 point to 46.4.

Tuesday’s advance/decline line opened positive with 18 incliners, 16 decliners and 1 flat ending with a negative close of 15 incliners, 19 decliners and 1 flat            

Metrics:  Tuesday, the IBB was down -1.96%, the XBI was up +0.01% while the VIX was up +0.35 points or +2% at 17.87

 

Q3 – August – 2 negative and 1 positive closes

  • July – 1 market holiday, 13 positive and 9 negative closes

Q2/25: June – 1 market holiday, 1 neutral, 9 negative and 11 positive closes, May – 1 market holiday, 10 negative and 11 positive closes and April – 11 positive and 10 negative closes

 

Coverage Dropped: bluebird bio (BLUE) Private Equity acquired, Blueprint Medicine (BPMC) acquired by SNY, Homology Medicine (FIXX), Sage Therapeutics (SAGE) acquired by SUPN, Verve Therapeutics (VERV) – acquired by LLY

Added: BioNTech (BNTX), Sarepta Therapeutics (SRPT), Supernus Pharma (SUPN), IQVIA Holdings (IQV) and Wave Life Sciences Ltd. (WVE)

 

Tuesday Closing UP (10 of 15) 

  • AxoGen (AXGN +$1.17 after Monday’s -$0.12),
  • IQVIA Holdings (IQV +$1.17),
  • Lenz Therapeutics (LENZ +$1.15 after Monday’s -$0.63),
  • BioNTech (BNTX +$1.04 after Monday’s +$2.69),
  • Supernus Pharmaceuticals (SUPN +$0.48 after Monday’s +$1.54),
  • Ultragenyx Pharmaceuticals (RARE +$0.46),
  • uniQure NV (QURE +$0.23),
  • Voyager Therapeutics (VYGR +$0.17),
  • Precigen (PGEN +$0.17),
  • Mesoblast (MESO +$0.16),

Flat (1)

  • Harvard Apparatus RT (OTCQB: HRGN)

Tuesday’s Closing DOWN (10 of 19): 

  • CRISPR Therapeutics (CRSP -$4.00 after Monday’s +$3.50),
  • Vericel (VCEL -$0.76 after Monday’s +$1.95),
  • Alnylam Pharmaceuticals (ALNY -$0.64 after Monday’s +$17.76),
  • Intellia Therapeutics (NTLA -$0.54 after Monday’s +$0.63),
  • Cellectis SA (CLLS -$0.49),
  • Beam Therapeutics (BEAM -$0.42),
  • Ionis Pharmaceuticals (IONS -$0.40 after Monday’s +$0.42),
  • Sarepta Therapeutics (SRPT -$0.35 after Monday’s +$1.19),
  • MiMedx (MDXG -$0.18 after Monday’s -$0.01),
  • Moderna (MRNA -$0.17),

 

The BOTTOM LINE: Today we’re seeing the sector pull back, after cell and gene therapy equities had a nice run on Monday. Today, valuations were “slapped” facilitating a cheapened sector

The market is … also bracing for a historically weak month … August is the worst month for the Dow in data going back to 1988, and the 2nd worst for the S&P 500 and Nasdaq according to the Stock Trader’s Almanac.

  • Investors should buckle up as August and September roll around, according to Canaccord Genuity pointing to the historical underperformance of the 2 months — particularly September, known as “The September Effect.”
  • “Going back to 1957, the S&P 500 in September has been down on average -0.74% and has shown positive performance only 43% of the time. August on its own is marginally better with an average return of ~0.20%, and Aug-Sep taken together is the worst-performing 2-month sequential combination on the calendar,” the bank wrote.

A macro perspective:

Pfizer (PFE) shares were up more than 2% in the premarket after the pharmaceutical giant posted quarterly results that beat analyst expectations.

  • PFE earned $0.78 per share on revenue of $14.65 B. PFE also hiked its full-year earnings outlook thanks to cost cuts.

 

Trouble ahead:

  • The Trump administration in April initiated a so-called Section 232 investigation on pharmaceutical products. That’s a legal authority that allows the secretary of Commerce to investigate the impact of imports on national security.
  • When it comes to his planned pharmaceutical tariffs, President Trump said that the levies could eventually reach up to 250%. That’s the highest tariff rate he’s threatened to date. <CNBC>
  • He said he will initially impose a “small tariff” on pharmaceuticals, but then in 1 year to 1 1/2 year “maximum” he will raise that rate to 150% and then 250%.

 

August is here to stay as July ended better than past months; although, I considered the so-called summer rally … “peripatetic or wandering.”

  • There are always some big ifs, especially given some of the headlines that could emanate after a past few months of news flatulence.

Welcome to my world of defining the “grey’ in our universe!

  • Right up front, “I also hate to be so negative or contrarian but, this is a NO spin zone and facts are its product; I can always be WRONG but … I am mostly EARLY!”

 

Earnings today:

Beam Therapeutics (BEAM) a net loss of -$102.3M or -$1.00 per share with revenue of $8.7 M and a cash position of $1.2 B and a runway beyond 2028

AxoGen (AXGN) a net income of +$579 K or +0.01 per share, revenue of $56.7 M, a cash position of $35.9 M with a runway until 2026

 

August is here to stay, Earnings to date:

Moderna (MRNA) a net loss of -$0.8 B, or -$2.13 per share with revenue of $142 M, an R&D and an SG&A decrease and a cash position of $7.5 B with a runway until 2026 <beats revenue estimate and earnings consensus>.

Sage Therapeutics (SAGE): net loss of -$49.7 M or -$0.79 per share, revenue of $23.2M, a cash position of $366 M – acquired

Vericel (VCEL): net loss of -$0.06 M or -$0.01 per share, revenue of $63.2M, a cash position of $164 M and a runway until 2027

Alnylam Pharmaceuticals (ALNY): net loss of -$66.3 M or -$0.51 per share, revenue of $773.7 M, a cash position of $2.86 B and a N/A runway

Lenz Therapeutics (LENZ): net loss of -$14.9 M or -$0.53 per share, revenue of $5 M, a cash position of $209.6 M and a runway until 2026

uniQure NV (QURE) a net loss of -$37.7 M, or -$0.69 per share with revenue of $5.3 M, an R&D increase and an SG&A decrease and a cash position of $377.7 M with a runway until 2H/27 <missed revenue estimate and consensus>

Ionis Pharmaceuticals (IONS) a net income of +124 M, or +$0.70 per share with revenue of $452 M, and a cash position of $2.3 B with a runway until FY28 < estimate and consensus beats>

MiMedx (MDXG) a net income of +$100 M or +$0.06 per share with revenue of $99 M and a cash position of $100 M with a runway until 2026.

BioNTech (BNTX) a net loss of (€)387 M or (€)1.60 per share with revenue of (€)260.8 M and a cash position of (€)160.8 B and a runway beyond 2027

Wave Life Sciences Ltd. (WVE) a net loss of -$50.5 m or -0.31 per share, revenue of $8.7 M, a cash position of $208.5 M with a runway until 2027

 

More earnings are a’comin: 8/5, Tuesday = Supernus Pharmaceuticals (SUPN) <Replaces/Acquired Sage Therapeutics (SAGE), AxoGen (AXGN) and Ultragenyx Pharmaceuticals (RARE), 8/6 – Wednesday Sarepta Therapeutics (SRPT), 8/7 Thursday = Intellia Therapeutics (NTLA) and Regenxbio (RGNX)

 

August begins as July ends: understand the “flow” …

  • 8/5 – Tuesday closed negative with 15 positive, 19 negative and 1 flat
  • 8/4 – Monday closed positive with 27 positive, 8 negative and 0 flat
  • 8/1 – Friday closed negative with 9 positive, 20 negative and 6 flats

Last week (July):

  • 7/31 - Thursday closed negative with 3 positive, 25 negative and 7 flats
  • 7/30 - Wednesday closed negative with 12 positive, 18 negative and 5 flats
  • 7/29 – Tuesday closed negative with 8 positive, 22 negative and 5 flats
  • 7/28 – Monday closed negative with 14 positive, 16 negative and 5 flats

 

“I hate to be so negative or contrarian but, this is a NO spin zone and truth is its product; I can always be WRONG but, I am mostly EARLY!”

  • If I have learned one thing as a former research analyst in a venture and public fund, operating executive, x-FBI, x-military officer and an adjunct (MBA) business school professor now a journalist; my life and your portfolio are largely tied to knowledge of price movements and questioning pricing targets and more.
  • I was once told by a “very” prominent figure early in my career, “write it right, keep it tight without hype and never lose the stride to guide the reader” – they were pretty simple instructions to follow!

 

Why do I keep repeating, so investors can make the connection …

The top three (3) performing in the session:   

  • Tuesday: Lenz Pharmaceuticals (LENZ), AxoGen (AXGN) and Supernus Pharmaceuticals (SUPN)
  • Monday: Alnylam Pharmaceuticals (ALNY), BioNTech (BNTX) and CRISPR Therapeutics (CRSP)
  • Friday: Alnylam Pharmaceuticals (ALNY), Ultragenyx Pharmaceuticals (RARE), and Vericel (VCEL)

The worst three (3) in the session: 

  • Tuesday: Vericel (VCEL), Alnylam Pharmaceuticals (ALNY) and Beam Therapeutics (BEAM)
  • Monday: Lenz Pharmaceuticals (LENZ), AxoGen (AXGN) and Compass Therapeutics (CMPX)
  • Friday: Moderna (MRNA), Beam Therapeutics (BEAM) and BioLife Solutions (BLFS)

 

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 it’s 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.