August 23, 2023 4:49pm

AGEN is NOT the first and NOT the last

News: Agenus (AGEN -$0.11) is laying off 91 workers as it trims its pipeline down to just 2 drugs. AGEN has temporarily stopping work on nearly all of its development programs, save for botensilimab and balstilimab, two antibodies that can work in combination with other drugs — including each other, in a duo AGEN terms "BOT/BAL" — to fight cancer by instigating immune cell responses.  <read 8-K in The Bottom Line>

Subscription is coming, it is not conscription but, an offer to join our collective of like-minded investors!  Join me … in the NO spin zone.

Pre-Open indications: 2 Hits and 1 Miss

Never leave an investor uninformed! 

If I have learned one thing as a former research analyst in a venture and public fund, operating executive, x-military officer and x-FBI, an adjunct (MBA) business school professor now a journalist; my life and your portfolio are largely tied to our knowledge of price movements and questioning pricing targets.


The Dow closed UP +184.35 or +0.54%, the S&P closed UP +48.48 or +1.10% while the Nasdaq closed UP +215.16 points (+1.59%)



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 climbed Wednesday, a decline in yields also buoyed sentiment.

Traders cheered a decline in yields. The benchmark 10-year Treasury yield, which hit its highest level since 2007, dropped more than 11 basis points to 4.21%.

Economic Data Docket: the start of a two-day Federal Reserve symposium in Jackson Hole, Wyoming, beginning Thursday. Fed Chair Powell is expected to deliver remarks Friday.


Wednesday (8/23) … RegMed Investors’ (RMi) Opening Bell: “the outlook for cell and gene therapy equities remains challenging. Investors await hints on the outlook for interest rates while fretting the probable of financings.” …


RegMed/Stem/Cell and Gene Therapy’s 35 covered equities’ Advance/Decline (A/D) lines: what happened – differences …

  • Wednesday’s advance/decline line opened positive at 32 up/ 2 down and 1 flat, stayed positive with 26 up/ 9 down and x flats at the mid-day, ending with a positive close of 26 incliners, 6 decliners and 3 flats


Pre-Open indications: 2 Hits <AxoGen (AXGN +$0.13), Beam Therapeutics (BEAM +$0.20)> and 1 Miss < Ultragenyx Pharmaceuticals (RARE +$0.52)>  


Ebb and flow:

  • Q3: August – 6 positive and 11 negative closes


Key Metrics:

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

  • Wednesday, the IBB was up +0.58% and the XBI was up +0.63%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Wednesday was down -0.99 point or -5.83% at 15.98


Closing Down (6 of 6):

  • uniQure NV (QURE -$0.13),
  • Agenus (AGEN -$0.11),
  • Editas Medicine (EDIT -$0.04 after Tuesday’s +$0.17 and Monday’s -$0.04),
  • Regenxbio (RGNX -$0.03 after Tuesday’s -$0.12 and Monday’s +$0.48),
  • Brainstorm Cell Therapeutics (BCLI -$0.02),
  • Sangamo Therapeutics (SGMO -$0.0015)


Flat (3):

  • Harvard Apparatus RM (HRGN)
  • BioLife Solutions (BLFS)
  • Sage Therapeutics (SAGE)


Closing Up (10 of 26):

  • CRISPR Therapeutics (CRSP +$1.53 after Tuesday’s +$1.04 and Monday’s -$0.21),
  • Alnylam Pharmaceuticals (ALNY +$1.00 after Tuesday’s +$0.65 and Monday’s +$2.70),
  • Ultragenyx Pharmaceuticals (RARE +$0.52 after Tuesday’s -$0.89 and Monday’s +$1.88),
  • Blueprint Medicine (BPMC +$0.42 after Tuesday’s -$1.21 and Monday’s +$1.26),
  • Ionis Pharmaceuticals (IONS +$0.40 after Tuesday’s +$0.12 and Monday’s -$0.35),
  • Verve Therapeutics (VERV +$0.40 after Tuesday’s -$0.05 after Monday’s -$0.06),
  • Bellicum Pharmaceuticals (BLCM +$0.2235),
  • Vericel (VCEL +$0.20 after Tuesday’s +$0.40 after Tuesday’s +$0.33 and Monday’s -$0.25),
  • Beam Therapeutics (BEAM +$0.20 after Tuesday’s -$0.40 after Monday’s +$0.36),
  • MiMedx (MDXG +$0.20),


Q3/23 – August

  • Wednesday closed positive with 26 incliners, 6 decliners and 3 flats


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

I follow the dictum, quoting Churchill that “short words are best, and the old words when short are best of all.”

It has been a cruel summer for Nasdaq index, which is on pace for its worst Augusts since 2015 and 2001 … markets will be on pins and needles regarding what the Fed will do all through September and into October.

investors are anxious to hear Powell's comments at Jackson Hole. Concerns the Fed will keep interest rates higher for longer have pushed up U.S. Treasury yields, and fanned worries about the impact of higher rates on businesses and consumers.


Cell and gene therapy sector equity flitted with the upside on Tuesday ascending to new heights on Wednesday to also close positive after “pooping the bed” most of last week and most of the month of august while upbeat economic data kept alive fears of interest rates remaining higher for longer.


August tends to frighten many stock market investors and historians.

•              The stock market is riding high after a strong performance in July, but August could be a difficult month for investors.

•              Data compiled by the Stock Trader’s Almanac shows the S&P 500 averages just a 0.1% gain in August. That makes it the third-worst month on average for the benchmark index. The Dow, meanwhile, averages a loss of 0.04% in August. <CNBC>


Happenings of consequence: On August 23, 2023, Agenus (AGEN) announced a strategic alignment and streamlining of its operations to support near-term clinical development, regulatory activities, and preparations for commercialization of its lead program of botensilimab and balstilimab. 

·         As part of this effort, Agenus Inc. (excluding its independently operating subsidiaries) is reducing its workforce by approximately 25%, which the company expects to result in savings of approximately $2.8 million by year-end, after accounting for the cost of the workforce reduction of approximately $1.4 million.

·         The workforce reductions are cash-based expenditures related primarily to severance payments. 

·         The company expects to recognize substantially all charges related to the workforce reduction in the quarter ending September 30, 2023. 

·         Beyond workforce reductions, the company expects to reduce spending by approximately $40 million by year-end 2023 on programs and activities outside of its strategic focus on botensilimab and balstilimab.

·         These estimates are subject to assumptions and actual results may differ.


Tip of the hat: Roche (RHHBY or ROG.SW), the Swiss drug giant inadvertently published promising data from a lung cancer drug trial, boosting shares of biotechs developing similar drugs, including iTeos Therapeutics (ITOS).


It hasn’t been a good month to report earnings…

Cell and gene therapy sector performance continues to suggest the results of earning season.

30 of 35 companies have reported so far in August. The average post-report reaction to these stocks has been 100% LPS (loss-per-share) consensus with many also missing revenue forecasts.

Q2/23 net losses earnings, cash positions and runway outcomes. LPS (loss-per-share) releases will present challenges to share pricing with outcomes included …


Right up front, “I also 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!”


The top three (3) performing in the session:

Wednesday: CRISPR Therapeutics (CRSP) - again, Alnylam Pharmaceuticals (ALNY) – again and Blueprint Medicine (BPMC)

Tuesday: CRISPR Therapeutics (CRSP), Alnylam Pharmaceuticals (ALNY) and Ultragenyx Pharmaceuticals (RARE)

Monday: Alnylam Pharmaceuticals (ALNY), Ultragenyx Pharmaceuticals (RARE) and Blueprint Medicine (BPMC)


While The worst three (3) in the session:

Wednesday: uniQure NV (QURE), Agenus (AGEN) and Editas Medicine (EDIT) 

Tuesday: Blueprint Medicine (BPMC), Ultragenyx Pharmaceuticals (RARE) and Beam Therapeutics (BEAM)

Monday: Vericel (VCEL), Sage Therapeutics (SAGE), Alnylam Pharmaceuticals (ALNY) – again, Graphite Bio (GPPH)  


I am definitely considered a contrarian depending on the session – one has to be a watcher of the ups and downs as well as measurer of sentiment. I am also a NO trust investor but, a validate and verify journalist/analyst.


The NO spin zone! U.S. public shareholders deserve accountability …


Harvard Apparatus Regenerative Technology (HRGN) formerly Biostage (OTCQB: BSTG) … as of 7/20/23 -- so many issues!

•              Accumulated deficit:  $85,901 M ++ (newest 10-K does NOT REVEAL)

•              Will HRGN ESCAPE the scandals when its “former” corporate name <Biostage BSTG)> was used by a former chairman and CEO Green initiating scandal plagued utilization of an Italian surgeon and the $5.9 M it took to settle out the executive responsibility as it was SHIFTED to the company shareholders and Harvard Bio (HBIO)???

•              On April 28, 2022, the Company entered into a Preferred Issuance Agreement, or PIA, with Harvard Bioscience (HBIO) dated as of April 27, 2022. Pursuant to the PIA, the Company and HBIO agreed that once HBIO had paid at least $4 million in certain settlement and related legal expenses, to satisfy the Company’s indemnification obligations with respect thereto, in lieu of paying cash, the Company would issue senior convertible preferred stock to HBIO that will contain terms as described in the PIA. <10-K>

•              On June 10, 2022, following the execution of a subscription agreement and HBIO providing evidence of payment of the requisite $4.0 million amount, the Company issued HBIO 4,000 shares of Series E Convertible Preferred Stock, or Series E Preferred Stock, at a price of $1,000 per share to satisfy the Company’s related indemnification obligations pertaining to the $4.0 million, in lieu of paying cash. <10-K>

•              Can this management team be TRUSTED by ANY shareholder other then major holders’ Chinese off-shore investors.

•              HRGN schedules earnings LPS (loss-per-share) – al but broke as 3–5-year clinical trial begins – four (4) years after IND approved

·         How much of HRGN has been funded by DPhone, the largest cell phone company in China; also, WHAT is its relationship with MSS, the Chinese national security organization??


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.