August 1, 2025 4:44pm

Deploy the Fed given multiple econs’ lack of strength!

Earnings today: 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>. Moderna shares have lost about 28.9% since the beginning of the year versus the S&P 500's gain of 7.8%.

Financing: Prime Medicine (PRME) closed its 43,7 M share offering and the full exercise of the 5.7 K underwriters’ option at $3.30 per share. The gross proceeds before deducting underwriting discounts and commissions and offering expenses, were approximately $144.2 M.

The present and future value of RegMed Investors (RMi) earnings sheds light on the cell and gene therapy sector’s risks to share pricing and the sector’s upside and downslide acrobatics

Never leave an investor uninformed! 

TGIF

My perspective is retail investors should roll-the-dice with econ readings until 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!

Traders locked in any gains as sector earnings get rolling, macro risks grow, and seasonality turns negative. Breadth is narrowing, valuations are stretched, and defensive positioning is quieting.

 

Friday’s RegMed Investors’ (RMi) pre-open: “Never get out of the boat” … https://www.regmedinvestors.com/articles/14044

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

 

Friday: The Dow closed DOWN -542.40 points or -1.23%, the S&P closed DOWN -101.38 points or -1.60% while the Nasdaq closed DOWN -472.32 points or -2.24%

  • Theme of the session, weak jobs and manufacturing data, new tariffs spark sell-off

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

  • The unemployment rate (4.2%) and monthly wage growth (0.3%) met consensus expectations, the economy added only 73 K jobs, missing the forecast of some 100 K. Also, job creation for the prior 2 months was revised down by a total of 258 K. Labor force participation also ticked down, from 62.3% to 62.2%.
  • Consumer sentiment improved slightly in July while inflation fears continued to recede, according to the University of Michigan’s latest survey. Sentiment rose to 61.7, up 1.6% monthly, still down 7.1% from a year ago but roughly in line with consensus. On inflation, the 1-year outlook dipped to 4.5% while the 5-year view fell to 3.4%, both the lowest readings since February.
  • Economic activity in the US manufacturing sector hit a 9-month low in July. The ISM manufacturing index nudged lower to 48, down 1 point and below the estimate for 49.5. The manufacturing sector has been in contraction for most of the past 2 years.

Friday’s advance/decline line opened negative with 5 incliners, 24 decliners and 6 flats ending with a negative close of 9 incliners, 20 decliners and 6 flats         

Metrics:  Friday, the IBB was up +0.28%, the XBI was up +0.27% while the VIX was up +3.84 points or +22.95% at 20.56

 

Q3 – August – 1 negative close

  • 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

 

Friday Closing UP (9 of 9)

  • Alnylam Pharmaceuticals (ALNY +$9.56 after Thursday’s +$52.44, Wednesday’s +$9.25, Tuesday’s +$5.76 and Monday’s -$4.02),
  • Ultragenyx Pharmaceuticals (RARE +$1.12 after Thursday’s +$0.18, Wednesday’s -$0.52, Tuesday’s +$0.05 and Monday’s +$0.27),
  • Vericel (VCEL +$0.69 after Thursday’s -$5.72 after Wednesday’s +$0.80, Tuesday’s -$1.59 and Monday’s +$1.33),
  • Cellectis SDA (CLLS +$0.44),
  • Prime Medicine (PRME +$0.30) – public offering is closed,
  • Lenz Therapeutics (LENZ +$0.19 after Thursday’s -$0.99, Wednesday’s -$0.91 and Tuesday’s +$0.165),
  • Ionis Pharmaceuticals (IONS +$0.05 after Thursday’s -$0.39, Wednesday’s +$1.89, Tuesday’s +$0.31 and Monday’s -$1.08),
  • Sangamo Therapeutics (SGMO +$0.0245),
  • Brainstorm Cell Therapeutics (BCLI +$0.0045),

Flat (6)

  • bluebird bio (BLUE) P/E acquired
  • Blueprint Medicine (BPMC) acquired by SNY
  • Harvard Apparatus RT (OTCQB: HRGN) Ponzi scheme
  • Homology Medicine (FIXX)
  • Sage Therapeutics (SAGE) acquired by Supernus Pharmaceuticals (SUPN)
  • Verve Therapeutics (VERV) – acquired by LLY

Friday’s Closing DOWN (10 of 20): 

  • Moderna (MRNA -$1.95 after Thursday’s -$2.59, Wednesday’s -$0.51, Tuesday’s -$1.33 and Monday’s -$0.24)
  • Beam Therapeutics (BEAM -$0.88 after Thursday’s -$0.44, Wednesday’s +$0.22, Tuesday’s -$0.90 and Monday’s -$0.89),
  • BioLife Solutions (BLFS -$0.45 after Thursday’s -$0.56 and Wednesday’s -$0.28),
  • AxoGen (AXGN -$0.42 after Thursday’s -$0.38, Wednesday’s -$0.23, Tuesday’s +$0.44 and Monday’s -$0.38),
  • Regenxbio (RGNX -$0.32),
  • Generation Bio (GBIO -$0.23),
  • Voyager Therapeutics (VYGR -$0.23),
  • uniQure NV (QURE -$0.23 after Thursday’s -$0.54, Wednesday’s +$0.78 and Tuesday’s -$1.30),
  • CRISPR Therapeutics (CRSP -$0.17 after Thursday’s -$1.42, Wednesday’s -$1.34, Tuesday’s -$4.73 and Monday’s -$1.01),
  • Agenus (AGEN -$0.16),

 

The BOTTOM LINE: Reiterating, “the cell and gene therapy sector continues its decline as well as its mojo” …

  • US stocks sank on Friday after President Trump officially hit virtually every US trading partner with sweeping tariff hikes, while the July jobs report showed signs of a labor market slowdown.
  • The small-cap Russell 2000 index was dragged down 2%, but it improved from its worst levels. The Russell 2000 is on track for 5 straight days of losses. It fell below its 200-day moving average and tested its 50-day moving average.
  • Losers squashed winners on the Nasdaq by nearly 3-to-1. The ratio was just over 12-5 negative on the NYSE.
  • Volume was higher on the NYSE and the Nasdaq compared with the same time Thursday.

In other news out of Washington …

  • Fed Governor Adriana Kugler is resigning. Kugler is part of the Federal Open Market Committee that sets interest rates. Her departure is effective Aug. 8.

Econs cause and effect:

  • Investors bought bonds with a vengeance after the July jobs report missed expectations, while job growth in May and June was revised sharply lower. The yield on the 2-year note plunged 21 basis points to around 3.74%. The 10-year yield fell 12 basis points to 4.25%.

The monthly US jobs report was weaker than expected with an unmitigated miss …

  • The retreat in stocks came as the July jobs report released Friday morning showed weaker-than-expected jobs growth. The prior 2 readings were also revised down sharply, indicating the labor market has been slowing down over the past 3 months. The unemployment rate ticked up to 4.2%.

Some healthcare news: Report of Medicare, Medicaid GLP-1 coverage

  • Shares of Novo Nordisk (NVO) and Eli Lilly (LLY) spiked at the open after the Washington Post reported that the Trump administration is planning to experiment with allowing Medicare and Medicaid to cover weight-loss drugs.
  • A plan obtained from the Centers for Medicare and Medicaid Services stated that state Medicaid programs and Medicare Part D insurance plans can voluntarily choose to cover NVO's Ozempic and Wegovy and LLY's Mounjaro and Zepbound for weight management.

 

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.

 

However, sector investor “worried” eyes should be focused on upcoming earnings releases, and a jam-packed econ week.

  • Maybe after all, I should have taken this week off … to avoid the nervous and the on-coming pain

 

More earnings are a’comin: 8/4 -Monday Cellectis SA (CLLS) and 8/5, Tuesday = AxoGen (AXGN) and Ultragenyx Pharmaceuticals (RARE), 8/7 Thursday = Intellia Therapeutics (NTLA) and Regenxbio (RGNX)

 

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.

 

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

  • 8/1 – Friday closed negative with 9 positive, 20 negative and 6 flats
  • 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:   

  • Friday: Alnylam Pharmaceuticals (ALNY), Ultragenyx Pharmaceuticals (RARE) and Vericel (VCEL)
  • Thursday: Alnylam Pharmaceuticals (ALNY), MiMedx (MDXG) and Ultragenyx Pharmaceuticals (RARE)
  • Wednesday: Alnylam Pharmaceuticals (ALNY), Lenz Pharmaceuticals (LENZ) and Vericel (VCEL)
  • Tuesday: Alnylam Pharmaceuticals (ALNY), Lenz Pharmaceuticals (LENZ) and AxoGen (AXGN)
  • Monday: Vericel (VCEL), Agenus (AGEN) and Cellectis SA (CLLS)

The worst three (3) in the session: 

  • Friday: Moderna (MRNA), Beam Therapeutics (BEAM) and BioLife Solutions (BLFS)
  • Thursday: Vericel (VCEL) Moderna (MRNA) and CRISPR Therapeutics (CRSP)
  • Wednesday: CRISPR Therapeutics (CRSP), Lenz Pharmaceuticals (LENZ) and Ultragenyx Pharmaceuticals (RARE)
  • Tuesday: CRISPR Therapeutics (CRSP), Moderna (MRNA) and uniQure NV (QURE)
  • Monday: Alnylam Pharmaceuticals (ALNY), Ionis Pharmaceuticals (IONS) and CRISPR Therapeutics (CRSP)

 

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!”

 

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.