Moderna Inc (MRNA) Quote

Suffering from

A medical coincidence

From the other side

Milestone marks a significant step toward producing mRNA vaccines in Canada by 2025


https://investors.modernatx.com/news/news-details/2024/Modernas-Canadian-Manufacturing-Facility-Receives-Drug-Establishment-License-From-Health-Canada/default.aspx

MRNA spends far too much, says WSJ’s “Heard-on-the-Street” column:

https://www.wsj.com/finance/stocks/pandemic-darling-moderna-needs-a-reality-check-3c375b0e Moderna’s massive pipeline of 45 therapies and vaccines will be the focus of its R&D day next Thursday. But what investors most want to see is that program being trimmed.

Moderna is now bleeding cash at a worrying pace. Last year it reported a $4.7 billion net loss, and it is now on track to lose at least another $3 billion this year, according to analyst estimates compiled by FactSet. The company has made the case that it should begin to break even by 2026. But that isn’t looking likely given the slow uptake of the company’s second product, an RSV vaccine that has struggled to gain market share against shots from Pfizer and GSK.

… The good news is that, given the size of the company’s massive pipeline, there is plenty of room to find something like $1 billion in cuts.

Cancer Vaccines Industry Research Report 2024: Market Poised for Exponential Growth with a Projected Value of $6.7 Billion by 2032

https://www.globenewswire.com/news-release/2024/09/05/2941536/0/en/Cancer-Vaccines-Industry-Research-Report-2024-Market-Poised-for-Exponential-Growth-with-a-Projected-Value-of-6-7-Billion-by-2032.html

$ANIX

Study shows that vaccination against RSV lowers the risk of hospitalization in people over 60

https://medicalxpress.com/news/2024-09-vaccination-rsv-lowers-hospitalization-people.html#google_vignette

Moderna’s First mRNA Mpox Vaccine Beats Licensed Rival Shots In Early Testing
https://www.forbes.com/sites/roberthart/2024/09/04/modernas-first-mrna-mpox-vaccine-beats-licensed-rival-shots-in-early-testing/

Do viruses exist?

The essence of science

Called the null hypothesis

What is the issue

Mother's RSV vaccine plea after baby's virus death-

https://www.bbc.com/news/articles/c5y3kvl9k0wo

Here we go!

Typo correction—The header of #msg-174969830 should say, "FDA approves PFE, MRNA COVID vaccines targeting KP.2 variant."

Patient in the UK is the first to receive a novel lung cancer vaccine
Unlike chemotherapy, the vaccine reduces the risk of toxicity to healthy, non-cancerous cells by enhancing the immune responses to target cancer cells, researchers said

$BNTX
https://www.insideprecisionmedicine.com/topics/oncology/global-trial-of-biontechs-mrna-based-lung-cancer-vaccine-launches/

Which was created through the vaccines
The First mRNA Vaccine for Melanoma WHO controls the FDA

Where does that go

Create the problem

Watch the reaction

Afford the solution

Simple business plan

Coming Soon: The First mRNA Vaccine for Melanoma........

Moderna and Merck have presented promising results from their phase 2b clinical trial that investigated a combination of a messenger RNA (mRNA) vaccine and a cancer drug for the treatment of melanoma.

Is mRNA set to shake up the world of cancer treatment? This is certainly what Moderna seems to think; the pharmaceutical company has published the results of a phase 2b trial combining its mRNA vaccine (mRNA-4157 [V940]) with Merck's cancer drug KEYTRUDA. While these are not the final results but rather mid-term data from the 3-year follow-up, they are somewhat promising. The randomized KEYNOTE-942/mRNA-4157-P201 clinical trial involves patients with high-risk (stage III/IV) melanoma following complete resection.

Relapse Risk Halved
Treatment with mRNA-4157 (V940) in combination with pembrolizumab led to a clinically meaningful improvement in recurrence-free survival, reducing the risk for recurrence or death by 49%, compared with pembrolizumab alone. The combination of mRNA-4157 (V940) with pembrolizumab also continued to demonstrate a meaningful improvement in distant metastasis-free survival compared with pembrolizumab alone, reducing the risk of developing distant metastasis or death by 62%. "The KEYNOTE-942/mRNA-4157-P201 study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over pembrolizumab alone in adjuvant melanoma", said Kyle Holen, MD, Moderna's senior vice president, after presenting these results.

Side Effects
The combined treatment also did not demonstrate more significant side effects than pembrolizumab alone. The number of patients reporting treatment-related adverse events of grade 3 or greater was similar between the arms (25% for mRNA-4157 [V940] with pembrolizumab vs 20% for KEYTRUDA alone). The most common adverse events of any grade attributed to mRNA-4157 (V940) were fatigue (60.6%), injection site pain (56.7%), and chills (49%). Based on data from the phase 2b KEYNOTE-942/mRNA-4157-P201 study, the US Food and Drug Administration and European Medicines Agency granted breakthrough therapy designation and recognition under the the Priority Medicines scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma.

Phase 3 Trial
In July, Moderna and Merck announced the launch of a phase 3 trial, assessing "mRNA-4157 [V940] in combination with pembrolizumab as adjuvant treatment in patients with high-risk resected melanoma [stages IIB-IV]." Stéphane Bancel, Moderna's director general, believes that an mRNA vaccine for melanoma could be available in 2025.

Moderna Receives European Commission Approval for RSV Vaccine mRESVIA(R)


https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-European-Commission-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx

PFE/MRNA/NVAX—Street consensus sales for 2H24 COVID vaccines:

https://www.barrons.com/articles/fda-approves-updated-covid-19-shots-pfizer-moderna-5d1d1229 Wall Street analysts expect roughly $2.5 billion in sales of Moderna’s Covid-19 vaccine in the second half of the year, according to FactSet, while they have penciled in $4.5 billion in sales for Pfizer’s version. From Novavax, they expect sales in the second half of just $210 million. The $4.5B 2H24 figure above for PFE is consistent with PFE’s own guidance of $5.0B for the full year (#msg-174835917), since PFE sold $550M of COVID vaccines in 1H24.

MRNA has not given 2024 guidance for COVID-vaccine sales specifically; rather, MRNA guided to $3.0-$3.5B of sales for COVID and RSV vaccines combined (#msg-174849487). In 1H24, MRNA sold $350M of COVID vaccines and its RSV vaccine had not yet launched.

FDA approves PFE, COVID vaccines targeting KP.2 variant:

https://finance.yahoo.com/news/pfizer-biontech-receive-u-fda-181500674.html (PFE)

https://finance.yahoo.com/news/moderna-receives-u-fda-approval-174700629.html (MRNA)

NVAX’s updated COVID vaccine is not ready yet.

FDA approved RNA Drugs: 21

RNA therapeutics in targeting GPCRs

https://www.cell.com/action/showPdf?pii=S2162-2531%2824%2900082-9

Moderna was the most shorted healthcare company at July-end, with short interest at 6.69%

https://www.washingtonpost.com/health/2024/08/16/new-covid-vaccine-pfizer-moderna-flirt-variant/

The good news about an mRNA vaccine is that if necessary, it could easily be adapted to work against any new
mpox variants that emerge and they can rapidly be manufactured.

mpox Curious about the status of @moderna_tx’s #mRNA #vaccines for #mpox and #smallpox?

With the ongoing #mpox outbreak, it’s crucial to know how the Phase 1/2 Clinical Trial that began in the UK earlier this year is progressing. #vaccineshttps://t.co/NrSZPvoPv1— Krutika Kuppalli, MD FIDSA (@KrutikaKuppalli) August 17, 2024

Cancer patients to join personalised vaccine trial

https://www.bbc.com/news/articles/c5yk7m9x8nmo

Cause unknown

Sudden death "epidemic"

Is "national security issue"

sometimes they come back
https://www.wsws.org/en/articles/2024/08/13/qmqx-a13.html

The math is not an opinion!

Funny, the population of the USA is 333.3 million (2022).

One million infected is 1 in 333 people.

That X poster for the Covid19 appears to have made a mistake........or they have terrible math skills.........or they have an agenda.

All labs cannot be wrong

Characteristics and behaviors distinguishing
(1:52:35)

Those in positions of power

BaggyPants

Personalized Cancer Vaccines Are the Future of Cancer Treatment. Here’s How They Work

https://www.verywellhealth.com/the-future-of-cancer-treatment-personalized-vaccines-8692668

KEYNOTE-603 Data Further Bolster Merck, Moderna's Bespoke mRNA Vaccine in NSCLC, Melanoma

https://www.precisionmedicineonline.com/precision-oncology/keynote-603-data-further-bolster-merck-modernas-bespoke-mrna-vaccine-nsclc

Great podcast. I will look him up

⚠️ BREAKING

U.S. Daily COVID-19 Infections Reach 1 Million

Currently, 1 in every 33 people in the U.S. is infected with COVID-19, a staggering figure that marks a 74% increase over the average infection rates of the past year. pic.twitter.com/WDXV50P5qb— SARS‑CoV‑2 (COVID-19) (@COVID19_disease) August 10, 2024

Might hit 78 before the next bounce!!

sometimes they come back
⚠️ BREAKING

🇨🇳 China Faces New COVID-19 Surge with Recombinant Variant XDV.1

Recent reports from China reveal a concerning resurgence of COVID-19 driven by a new recombinant variant, XDV.1, which combines Delta and Omicron strains. pic.twitter.com/hDLnOgqBUt— SARS‑CoV‑2 (COVID-19) (@COVID19_disease) August 9, 2024

https://www.cdc.gov/mmwr/volumes/73/wr/mm7331a2.htm?s_cid=mm7331a2_w

next stop $105

In the fields of medicine and biology

~~~ Requires logical thinking in science ~~~
(1:03:56)

In general

Mark Twain statement:

It's not what you don't know

That gets you into trouble

It's what you know for sure

That just ain't so Dr. Tom Cowan

Depends on its intention

Never underestimate RNA: how a molecule went from bit player to star of the show:

https://www.nature.com/articles/d41586-024-02537-9

Guess what a reduction in guidance gives opportunity to?? Low bar to jump in the future!! Manipulation at it's finest!! Lol 😆

Cathie Wood has been bad luck but I couldn't resist!! Oversold!!

What is

Unvaccinated blood

"Buy when there's blood in the streets," was something famous banker Baron Rothschild once advised, suggesting the time to invest is when everyone else is fleeing a particular asset or the market in general. And superstar investor Cathie Wood did just that last week when she added to her holding of Moderna (MRNA -8.06%), buying shares for both her flagship Ark Innovation fund and her Ark Genomic Revolution fund. Moderna stock crashed 27% in one trading session after the company lowered its full-year revenue forecast.

https://www.fool.com/investing/2024/08/04/cathie-wood-bought-this-stock-after-its-27-drop/

Cathie Wood's Ark Adds Over $19M Worth Of Moderna Shares After Thursday's 21% Plunge On Guidance Cut

https://www.benzinga.com/general/biotech/24/08/40130265/cathie-woods-ark-adds-over-19m-worth-of-moderna-shares-after-thursdays-21-plunge-on-guidance-cut

MRNA 2Q24 CC transcript:

https://finance.yahoo.com/news/q2-2024-moderna-inc-earnings-041533848.html

Troubling bird flu study suggests human cases are going undetected

https://arstechnica.com/science/2024/08/troubling-bird-flu-study-suggests-human-cases-are-going-undetected/

https://www.fool.com/earnings/call-transcripts/2024/08/01/moderna-mrna-q2-2024-earnings-call-transcript/

"This is a speed bump. I'm not pleased about it, obviously. This company, most of the value is in the products that are going to be launching in the next couple of years," Bancel said.

For now, he added, Moderna's story is a "Northern Hemisphere, winter season business."

MRNA—(-21%)—reports 2Q24 results—cuts 2024 sales guidance:

https://finance.yahoo.com/news/moderna-reports-second-quarter-2024-103000708.html The Company revises its 2024 expected net product sales to $3.0 to $3.5 billion from its respiratory franchise. …The update in product sales is driven by three primary factors: very low EU sales in 2024, potential revenue deferrals for certain international sales into 2025, and an increasingly competitive environment for respiratory vaccines in the U.S. The 2024 sales guidance given three months ago was $4B, so the new guidance is a reduction of $500M-$1.0B.

The third reason for the guidance cut cited above — “an increasingly competitive environment for respiratory vaccines in the U.S.” — is not well stated. The competition per se for respiratory vaccines in the US has not increased (the three players in RSV vaccines remain GSK, PFE, and MRNA); however, the CDC reduced the addressable US market for RSV vaccines by omitting adults age 60-74 without increased risk factors for severe disease, while also postponing any recommendation about booster shots (https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/12-RSV-Adult-Melgar-508.pdf ).

The first two reasons cited above for the guidance cut — “very low EU sales in 2024” and “potential revenue deferrals for certain international sales into 2025” are essentially the same issue: PFE/BNTX have locked up most of the European market for COVID vaccines in 2024-2025.

our Chief Financial Officer Jamey Mock sat down to provide more insight into our financial performance, challenging market dynamics, and our focus for the second half of the year.

https://www.modernatx.com/en-US/media-center/all-media/blogs/recapping-q2-2024-earnings-report

punctured with 10 vaccines-------

Research and development expenses for the second quarter of 2024 increased by 6% to $1.2 billion, compared to the second quarter in 2023.

useless thing.....