Moderna Inc (MRNA) Options

What happened to the NIH director

So many have yet

To be disclosed

https://www.marketbeat.com/instant-alerts/nasdaq-mrna-sec-filing-2024-09-22/

With Pfizer hitting a stumbling block, Moderna’s COVID-19/influenza vaccine, mRNA-1083, could be the first such combination vaccine to reach the market. In June, the company posted results from a Phase III trial that showed mRNA-1083 produced a strong immune response against both COVID-19 and influenza. In releasing the results, Moderna also became the first and, due to Pfizer/BioNTech’s struggles, only company to date to post positive Phase III results for a combination COVID-19/influenza vaccine.

https://www.biospace.com/drug-development/5-late-stage-mrna-vaccines-to-watch

That's a clcikbait article, IMO. NVO's working with a small company who has some expertise in RNA does not make NOVO a competitor of MRNA.

Novo Nordisk Just Took a $530 Million Step Onto Moderna's Turf. Here's What It Means for Both Stocks

https://www.fool.com/investing/2024/09/19/novo-nordisk-just-took-a-530-million-step-onto-mod/

$RELAX

Buy the Fear, Sell the Greed$$$$$$

That is the question

Why does the NIH own half

Of all MRNA injections

I do not know, what do you think? "It has to bounce back"

Moderna was getting too big, too fast. "The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these 10 products to patients, slow down the pace of new R&D investment, and build our commercial business," said chief executive officer Stéphane Bancel.
This is after -- just last year -- forecasting the launch of as many as 15 new products over the next five years.

THE WRITING IS ON THE WALL

https://www.fool.com/investing/2024/09/14/after-moderna-shocking-news-is-stock-a-buy-or-sell/

MRNA how much lower can it go

https://www.oncologypipeline.com/apexonco/accelerated-path-closes-modernamercks-immunotherapy

The journey is long and full of dangers.

The FDA’s issue with mRNA-4157 is unclear but it’s possible that, with the melanoma sector already well served, the agency is waiting for a clear overall survival benefit.

Scientists are hailing a new dawn in cancer treatment after a groundbreaking vaccine stopped the growth of tumours and the development of new ones in half of patients in the first-in-human study.

The mRNA-4359 vaccine works by teaching the immune system to identify and attack cancer cells

The work
https://www.msn.com/en-gb/health/other/cancer-breakthrough-as-vaccine-revs-up-immune-system-to-stop-tumours-and-destroy-disease-in-world-first/ar-AA1qwwX1?apiversion=v2&noservercache=1&domshim=1&renderwebcomponents=1&wcseo=1&batchservertelemetry=1&noservertelemetry=1

https://www.modernatx.com/en-US/media-center/all-media/blogs/strategic-priorities-at-R-D-Day

Moderna is due to present the data from the first-in-human study of mRNA-4359 on 14 September at the European Society of Medical Oncology meeting, taking place between 13 September and 16 September in Barcelona, Spain.

mRNA-4359 data https://finance.yahoo.com/news/esmo-moderna-mrna-solid-tumour-101238212.html

What's in this vaccine?

That shows positive results

What makes it work

Otherwise

Why be a mouthpiece

Provided that the phase-3 trial is successful. MRNA acknowledged yesterday that FDA accelerated approval for mRNA-4147 based on phase-2 data is no longer under consideration

Moderna to launch skin cancer vaccine as soon as 2025: CEO

https://asia.nikkei.com/Business/Pharmaceuticals/Moderna-to-launch-skin-cancer-vaccine-as-soon-as-2025-CEO

Cancer vaccine breakthrough as tests show positive results on patients with tumours
The jab, known as mRNA-4359, is developed by Moderna

Researchers found tumours did not grow and no new tumours appeared in eight of the 16 patients who were evaluated

Scientists use a tumour sample, along with DNA sequencing and artificial intelligence, to create a jab specific to the patient’s tumour.

https://www.independent.co.uk/news/health/cancer-vaccine-jab-lung-mrna4359-b2611858.html

MRNA—(-17%)—cuts costs, pares pipeline—investors unimpressed:

https://finance.yahoo.com/news/moderna-r-d-day-highlights-100000130.html

Annual R&D expenses, expected to be $4.7B in 2024, will be reduced to $3.6-3.8B by 2027. Cumulatively, R&D expenses during the 2025-2028 period will be reduced by 20%. Such a cutback is apparently too little and too slow to placate investors.

Perhaps more important, MRNA now says it expects to reach break-even cash flow in 2028—two years later then the previous guidance.

Moreover, MRNA issued 2025 revenue guidance of $2.5-3.5B, which is down from the (previously reduced) 2024 guidance of $3.0-3.5B (#msg-174849487).

Please see #msg-175048423 for related info.

Focuses on ten product approvals through 2027

"Moderna now has five respiratory vaccines with positive Phase 3 results and expects to submit three for approval this year. In addition, we have five non-respiratory products in pivotal studies across cancer, rare diseases and latent vaccines with potential for approval by 2027. Our demonstrated probability of success in R&D has been higher than industry standards at every stage of development," said Stéphane Bancel, CEO of Moderna. "The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these 10 products to patients, slow down the pace of new R&D investment, and build our commercial business."



Moderna's broad clinical success and recent commercial challenges necessitate a more selective and paced approach to its research and development investment. Through portfolio prioritization and cost efficiencies, the Company expects to reduce annual research and development expense by approximately $1.1 billion starting in 2027. During this time, Moderna will expand its commercial portfolio into oncology, rare diseases, and first-in-class non-respiratory vaccines. The Company expects this strategy to yield 10 product approvals over the next three years.

Cash and Investments: Year-end cash and investments for 2025 are projected to be approximately $6 billion.

Moderna plans to break even on an operating cash cost basis (which excludes stock-based compensation, depreciation and amortization expense) with $6 billion in revenue. The Company expects to achieve this in 2028. The Company has sufficient capital to fund its plans until achieving break even on a cash cost basis without raising additional equity.



https://investors.modernatx.com/news/news-details/2024/Moderna-RD-Day-Highlights-Progress-and-Strategic-Priorities/default.aspx


launch pad$$$$$$$$

So much noise

Can't pay attention

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