May 7, 2024 4:41pm

As I had stated, “let’s not forget about volatility”

News: Ligand Pharmaceuticals (LGND) and Agenus (AGEN -$0.95) have entered into a royalty financing agreement to support AGEN’s in the ongoing BOT/BAL clinical development program. <further terms below>

A 360-degree review of the who, why, when and what happened in the sector as the market and economics surround your portfolio’s defense or offence.

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The present and future value of RegMed Investors (RMi) NEWS sheds light on the stem, cell and gene therapy sector’s risks to share pricing and the sector’s upside acrobatics and potential downslides.

I write this blog/newsletter about – facts in evidence! 

 

Tuesday: The Dow closed UP +31.99 points or +0.08%, the S&P closed UP +6.96 points or +0.13% while the Nasdaq closed DOWN -16.69 points or -0.10%

 

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 coming-off a winning session, as investors rode momentum from Monday and some of last week after fresh U.S. jobs data alleviated concerns that the economy was too hot and Fed ruled out an interest rate hike as a next move.

 

From the title: Ligand Pharmaceuticals (LGND) and Agenus (AGEN)

  • Including its planned confirmatory P3 trial in its lead indication of patients with metastatic, relapsed/refractory colorectal cancer not microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR), who are without active liver metastases (r/r MSS CRC NLM), along with other launch readiness activities.
  • Under the terms of the agreement, Ligand will pay $75 million to Agenus at closing. In addition, Ligand has the option to invest an additional $25 million on the same terms on a pro rata basis. In return for the initial $75 million payment, Ligand will receive 18.75% of the future royalties and 31.875% of the future milestone payments related to six of Agenus’ clinical-stage partnered oncology programs, including BMS-986442 (Bristol Myers Squibb), AGEN2373 (Gilead Sciences), INCAGN2385 and INCAGN2390 (Incyte), MK-4830 (Merck), and UGN-301 (UroGen Pharma). Ligand’s portion of the milestones related to these six programs has the potential to exceed $400 million, with royalties in the low single digits. In addition, Ligand will also receive a 2.625% royalty on future global net sales generated by BOT/BAL. The royalties and milestone payments owed to Ligand could be adjusted up or down based upon pre-determined future events and achievements of certain milestones.

 

RegMed Investors (RMi) Research Note: Q1/24 earnings reporting dates, net losses, cash positions, revenue and runway outcomes … https://www.regmedinvestors.com/articles/13441   

RegMed Investors (RMi) - Q1/24 Cell and Gene Therapy Earnings Scorecard Results … https://www.regmedinvestors.com/articles/11628

 

Advance/Decline (A/D) Line:

  • Tuesday’s advance/decline line at the open was negative with 10 incliner, 22 decliners and 3 flats; ending with a negative close of 16 incliners, 18 decliners and 1 flat
  • Monday’s advance/decline line at the open was positive with 217 incliner, 16 decliners and 2 flats; ending with a positive close of 17 incliners, 15 decliners and 3 flats

 

Ebb and flow of MY covered sector cell and gene therapy session daily “endings”:

Q2/24: 4 positive and 1 negative closes

  • April; 16 negative and 6 positive closes

 

Key Metrics:

The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:

  • Tuesday, the IBB was up +0.20% and the XBI was down -0.17%
  • Monday, the IBB was up +0.05% and the XBI was up +0.67%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was down -0.25 point or -1.85% at 13.24
  • Monday was down -0.01 point or -0.07% at 13.48

 

Tuesday’s Closing Down (10 of 16):

  • CRISPR Therapeutics (CRSP -$1.53 after Monday’s +$1.17)
  • Ionis Pharmaceuticals (IONS -$1.35 after Monday’s +$0.31),
  • Ultragenyx Pharmaceuticals (RARE -$1.05 after Monday’s +$0.26)
  • Agenus (AGEN -$0.94 after Monday’s -$0.12)
  • Fate Therapeutics (FATE -$0.34 after Monday’s +$0.16),
  • Adverum Biotechnology’s (ADVM -$0.32 after Monday’s +$0.23)
  • Sage Therapeutics (SAGE -$0.27 after Monday’s -$0.69)
  • Verve Therapeutics (VERV -$0.25),
  • Beam Therapeutics (BEAM -$0.25 after Monday’s -$0.35
  • Cellectis SA (CLLS -$0.25),

Flat (1):

  • Bellicum Pharmaceuticals (BLCM +$0.07) – dropped

Tuesday’s Closing Up (10 of 18):

  • Alnylam Pharmaceuticals (ALNY +$3.11 after Monday’s -$1.11),
  • Vericel (VCEL +$2.58 after Monday’s -$0.89
  • Blueprint Medicine (BPMC +$2.30 after Monday’s -$0.94)
  • BioLife Solutions (BLFS +$0.45),
  • Solid Biosciences (SLDB +$0.42),
  • Lenz Therapeutics (LENZ +$0.25 after Monday’s -$0.28),
  • Prime Medicine (PRME +$0.17 after Monday’s -$0.19),
  • Intellia Therapeutics (NTLA +$0.16 after Monday’s +$0.12)
  • MiMedx (MDXG +$0.16 after Monday’s -$0.24),
  • AxoGen (AXGN +$0.16 after Monday’s -$0.12)

 

Q2/24 – May

  • Tuesday closed negative with 16 incliners, 18 decliners and 1 flat
  • (5/6) Monday closed positive with 17 incliners, 15 decliners and 3 flats
  • Friday closed positive with 22 incliners, 12 decliners and 1 flat
  • Thursday closed positive with 25 incliners, 9 decliners and 1 flat
  • Wednesday closed positive with 28 incliners, 6 decliners and 1 flat

 

The BOTTOM LINE: As I have written, “this week continues the Q1 financial performance elements of cell and gene therapy companies that sheds light on share value.”

  • Equites are currently trading "a questionable fair value" since they are trading today lower after recently higher so far this month of May after a rotten April.
  • There is also a "lop-sided risk to the downside."

Moving forward, watch-out for the future;

Inflation lodged above the U.S. Federal Reserve's 2% target could leave policymakers saddled with the difficult choice in coming months of how much risk to take with economic growth and the job market for what may only be modest further improvements in the pace of price increases.

Inflation has been largely stalled for the first three months of the year at a rate, roughly 2.7%, that policymakers regard as still too far above their target to declare the job finished, but also so close to it they've been reluctant to yet say that further rate increases may be likely. <Reuters>

Reporting today and share pricing:

  • BEAM (-$0.25),
  • IONS (-$1.35),
  • QURE (+$0.10) and
  • AGEN (-$0.94)

Earnings: https://www.regmedinvestors.com/articles/11628

  • RARE: Q1 loss
  • SAGE: Q1 loss
  • MDXG: Q1 loss
  • AXGN: Q1 loss
  • BPMC: net income
  • BEAM: Q1 loss, no revenue
  • IONS: Q1 loss, misses revenue and EPS estimate
  • AGEN: Q1 loss, misses revenue and EPS estimate
  • ALNY:  Q1 loss, tops revenue estimate and narrow miss on EPS
  • AXGN: Q1 loss, lags revenue estimates
  • BPMC: Q1 net incomes, surpasses revenue estimates

Earnings whispers:

  • BioLife Solutions (BLFS) to deliver a year-over-year increase in earnings on lower revenues. BLFS is expected to post quarterly loss of $0.26 per share in its upcoming report, which represents a year-over-year change of +18.8%. Revenues are expected to be $29.3 million, down 22.3% from the year-ago quarter.
  • Adverum Biotechnologies (ADVM) to deliver a year-over-year increase in earnings on lower revenues
  • CRISPR Therapeutics (CRSP) Revenues in the to-be-reported quarter are likely to have been driven by collaboration revenues from Vertex. The Zacks Consensus Estimate for total revenues stands at $8.31 million.
  • From Zacks investment Research

The top three (3) performing in the session:  

  • Tuesday: Alnylam Pharmaceuticals (ALNY), Vericel (VCEL) and Blueprint Medicine (BPMC)
  • Monday: CRISPR Therapeutics (CRSP), Mesoblast (MESO) and Cellectis SA (CLLS)

The worst three (3) in the session:

  • Tuesday: CRISPR Therapeutics (CRSP), Ultragenyx Pharmaceuticals and Ionis Pharmaceuticals (IONS)
  • Monday: Alnylam Pharmaceuticals (ALNY), Blueprint Medicine (BPMC) and Vericel (VCEL

 

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 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.