Novavax Inc (NVAX)

[JoeForkeyBolo]

Moths and tree bark: How the Novavax vaccine works

This is an informative article from 2022 I came across while researching Matrix-M, the Novavax proprietary adjuvant. Worth a read.

https://www.nebraskamed.com/COVID/moths-and-tree-bark-how-the-novavax-vaccine-works

July 21, 2022

A fourth COVID-19 vaccine has been authorized in the United States. Called Novavax, it's a more traditional vaccine that uses moth cells and tree bark. Instead of an mRNA vaccine (Pfizer, Moderna) or a viral vector vaccine (Johnson & Johnson), Novavax is a subunit protein vaccine.

Infectious diseases expert Diana Florescu, MD, led the phase 3 clinical trial of the Novavax vaccine at the University of Nebraska Medical Center (UNMC). "Diversity in vaccine production helps increase the number of patients vaccinated," says Dr. Florescu. "Some might not accept mRNA vaccines, while others may be allergic to certain ingredients."

For example, some are allergic to polyethylene glycol (PEG), an ingredient in the mRNA (Pfizer and Moderna) vaccines. There's no polyethylene glycol (PEG) in Novavax.

How does the Novavax vaccine work?

The Novavax COVID-19 vaccine contains a protein (made using moth cells) plus an adjuvant (made from tree bark). An adjuvant is an ingredient added to boost a person's immune response, creating higher levels of antibodies.

The Novavax vaccine uses a telltale piece of the coronavirus: the notorious spike protein. All alone, the spike protein is harmless and can't cause COVID-19. When your immune system encounters the lonely spike protein, it produces antibodies against it. This gives you protection against future COVID-19 infection.

"Unlike mRNA vaccines, the spike protein is already premade in the Novavax vaccine. It's a shortcut," explains Dr. Florescu. "All the synthesis happens outside the body and we just give the end product: the spike protein."

Like other COVID-19 vaccines, Novavax does not cause COVID-19 infection. It can't get you sick. This vaccine doesn't contain either live or inactivated virus.

How did they get the spike protein?

The Novavax method uses moth cells to make spike proteins:

1. Researchers select the desired genes that create certain SARS-CoV-2 antigens (spike protein).
2. Researchers put the genes into a baculovirus, an insect virus.
3. The baculovirus infects moth cells and replicates inside them.
4. These moth cells create lots of spike proteins.
5. Researchers extract and purify the spike proteins.

"The Novavax vaccine has no genetic material, only proteins," says Dr. Florescu. "The vaccine technology is more traditional, and it's very similar to a protein-based influenza vaccine."

Influenza vaccines have also used this moth cell factory method.

What does the adjuvant (soapbark tree extract) do?

Adjuvants increase the immune response to a vaccine. In this vaccine, soapbark tree extract adjuvant makes achieving immunity possible with a smaller dose of the spike protein.

Matrix-M is the adjuvant used by Novavax. It is based on a saponin extracted from the soapbark tree (Quillaja saponaria). The soapbark extract encourages immune cells to activate, generating a more potent immune response.

Saponins are found naturally in various plant species like beans and green peas. They're used in agriculture, animal feeds, veterinary vaccines and human food. Saponins can boost immune responses to proteins. Using the Matrix-M adjuvant, a smaller dose of spike protein achieves the desired immune response.

[JoeForkeyBolo]

Updated Novavax Covid-19 vaccines could be available as early as next week

https://www.cnn.com/2024/08/30/health/novavax-covid-shot-fda/index.html

CNN
—
The US Food and Drug Administration on Friday authorized an updated version of the protein-based Novavax Covid-19 vaccine for use in people 12 and up. Doses could be available by the end of next week.

[JoeForkeyBolo]

Novavax 2024-2025 Formula COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

https://ir.novavax.com/press-releases/2024-08-30-Novavax-2024-2025-Formula-COVID-19-Vaccine-Now-Authorized-and-Recommended-for-Use-in-the-U-S

August 30, 2024

• Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S.
• Novavax's vaccineis the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19

GAITHERSBURG, Md., Aug. 30, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Novavax's vaccine is included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024.

Pre-filled syringes of the vaccine will be available in thousands of locations, including retail and independent pharmacies and regional grocers, following the Center for Biologics Evaluation and Research release of vaccine batches.

"Today's authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Our updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1."

In June, the CDC's Advisory Committee on Immunization Practices voted unanimously in favor of a universal recommendation for the use of 2024-2025 COVID-19 vaccines authorized under EUA or approved by Biologics License Application in individuals aged six months and older, regardless of specific viral strains.1 As discussed at the June 2024 U.S. FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to target JN.1, the parent strain of the most common currently circulating variants.2,3 Novavax filed for JN.1 in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization to target the JN.1 lineage this fall.2,4,5

The EUA was based on non-clinical data that showed Novavax's updated vaccine provides protection and cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1 In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

AUTHORIZED USE IN THE U.S.
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has not been approved or licensed by the FDA but has been authorized for emergency use by the FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.

The EUA of this product will remain in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the authorization is revoked sooner.

VACCINE AUTHORIZATION (U.S.)
Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

(Vaccine safety information available by accessing the article link above)

[DewDiligence]

FDA grants EUA for NVAX's JN.1 COVID vaccine:

https://www.prnewswire.com/news-releases/fda-authorizes-updated-novavax-covid-19-vaccine-to-better-protect-against-currently-circulating-variants-302235235.html

Note that the PFE and MRNA updated COVID shots recently approved by the FDA target the KP.2 variant rather than JN.1 (#msg-174969836). This distinction probably has little consequence, however.

See #msg-174969866 for related info.

[JoeForkeyBolo]

I would rather pay out of pocket for the Novavax vaccine than risk another mRNA vaccine provided for free by the government. But that's just me, knowing what I now know about the risks of mRNA vaccines and my own experience after taking the initial Pfizer mRNA Covid vaccine in 2021. After many studies around the world have exposed these dangers, some countries are moving away from the mRNA Covid vaccine in favor of protein-based vaccines. It's unfortunate Canada made this choice. I'm glad I don't live in a country that forces citizens to get the mRNA vaccine, or nothing at all.

I watched the FDA advisory panel discussions and presentations by the vaccine makers when they unanimously recommended the JN.1 target and mentioned Novavax numerous times in their reasonings, to give people a choice for a non-mRNA option. Peter Marks tried and couldn't get them to agree to target KP.2 with his "freshest milk" argument, so he overrode their recommendation the FDA official decision targeted KP.2, which as the panel discussed, would likely not be the dominant strain by the time the vaccines were available to the public. They were right and Novavax targeting JN.1 was right, but Marks continues to play his games to give Pfizer and Moderna the edge in initial sales. But I believe the public is more knowledgeable about the mRNA risks and will still wait for Novavax. Peter Marks doesn't seem to be connected to the reality of how things are today. He's still using last year's playbook. With a change in the White House administration that I believe is coming, Marks will likely be sent packing. He may join the Pfizer board to cash in, but it's a new ball game with Sanofi doing a lot of Novavax's heavy lifting starting in 2025.

One final thought... Novavax will announce their new product direction in the remaining months of 2024. Also, I expect other partnerships to be announced for their Matrix-M adjuvant. FDA can play their little games now, but Novavax has a new playbook and FDA is still using the old one. I bought more shares today. 😎

[justin77]

As usual the FDA is slowing us down once again. It is so unfortunate and we will miss a lot by the time they are. Canada even said today will not be offering NVAX! Go figure. The world has an agenda to inject more MRNA in our system for a specific reasons.

[JoeForkeyBolo]

Added more NVAX shares. 😎

[DewDiligence]

Ok—got it.

[JoeForkeyBolo]

Novavax isn't targeting the KP.2 variant, but the JN.1 lineage, which provides strong immune support for KP.2 and KP.3 variant lines, including the more recent mutations along the JN.1 lineage. Novavax made the decision and and were already in production "at risk" prior to the 16-member FDA advisory panel unanimously recommended all vaccine makers target JN.1 as this was the "trunk of the tree" and would be the best solution for the 2024-25 vaccine season because the mutations were occurring faster than in previous seasons, and targeting a specific variant was riskier. Peter Marks took it upon himself to override the panel recommendation and once again try to leave Novavax at a disadvantage.

Notice how all the media stories about the mRNA vaccine approvals imply that Novavax will not be as effective as mRNA because they targeted KP.2 and Novavax targeted JN.1. The reality is the Novavax vaccine is superior because of it's Matrix M adjuvant and will prove more effective with higher antibody levels and fewer side effects than the mRNA vaccines of the competitors. Peter Marks' "freshest milk" analogy was pathetic, because vaccine formulation strategy is magnitudes more complex than shopping for milk and many more factors are involved that simply production date.

[DewDiligence]

I'm referring to the vaccine targeting the KP.2 variant (not the JN.1 variant).

[JoeForkeyBolo]

Novavax's Covid vaccine IS ready and has been for several weeks. Corrupt FDA will delay approval again as they did last year to give mRNA vaccines a head start. Good luck with that plan, Peter Marks, as many people are never going the mRNA vaccine route again after experiencing all the health issues associated with that technology, and will wait for the excellent protein-based Novavax vaccine.

[DewDiligence]

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.

[JoeForkeyBolo]

Added more NVAX shares today. 😎

[Bluewater2023]

Might be soon if it drops below $8.85 and opens below it

[JoeForkeyBolo]

Serious investors are loading up at great prices after this morning's earnings call. Some investors misinterpreted the news pre-market and dumped, but Jacobs conveyed a very positive future for Novavax on the call. The data supporting Matrix M in potential uses outside of vaccines was especially promising and speaks to the value and likelihood of more biotech partnerships like the Sanofi deal in the future.

Glad to be a shareholder in Novavax. 👍️

[JoeForkeyBolo]

Novavax – A Promising Vaccine Powerhouse Poised for Transformative Growth

Beyond SPX
Published on JULY 31, 2024

https://beyondspx.com/2024/07/31/novavax-inc-nasdaqnvax-a-promising-vaccine-powerhouse-poised-for-transformative-growth-2/

Overview

Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that has emerged as a leading player in the global vaccine market. With a focus on innovative vaccine technologies and a robust pipeline of promising candidates, Novavax is well-positioned to capitalize on the growing demand for effective and safe vaccines.

Business Overview

Novavax is a biotechnology company that promotes improved global health through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticle vaccines designed to address global health needs. Novavax’s vaccine candidates are nanostructures of conformationally correct recombinant proteins that mimic those found on pathogens, enabling the immune system to recognize target proteins and develop protective immune responses.

A key differentiator within Novavax’s platform is its proprietary Matrix-M™ adjuvant. This adjuvant has enabled potent, well-tolerated, and durable efficacy by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes. This, in turn, activates antigen-presenting cells, T-cell and B-cell populations, and plasma cells, which promote the production of high-affinity antibodies and an immune-boosting response. These immune-boosting and dose-sparing capabilities contribute to the adjuvant’s highly unique profile.

Novavax’s clinical pipeline encompasses vaccine candidates for infectious diseases, with its COVID-19 prototype vaccine (NVX-CoV2373) and its COVID-19 updated vaccine (NVX-CoV2601) as its lead products. The company’s updated vaccine has received authorization from the U.S. FDA, the European Commission, the WHO, and several other countries globally. Beyond its COVID-19 vaccine, Novavax’s clinical pipeline includes a COVID-Influenza Combination (CIC) vaccine candidate and a seasonal influenza vaccine candidate. Additionally, Novavax’s Matrix-M™ adjuvant is being used for collaboration in the R21/Matrix-M™ adjuvant malaria vaccine, which recently received authorization in several countries and prequalification by the WHO.

Financials
Novavax’s financial performance has been marked by significant growth and investment in its vaccine development efforts. For the fiscal year ended December 31, 2023, the company reported annual revenue of $983,705,000, a substantial increase from the previous year. However, the company’s annual net income was -$545,062,000, reflecting the significant investments made in research and development to advance its vaccine pipeline.

The company’s annual operating cash flow was -$717,558,000, and its annual free cash flow was -$776,364,000, indicating the capital-intensive nature of Novavax’s business model as it continues to invest in its vaccine development and manufacturing capabilities.

In the first quarter of 2024, Novavax reported total revenue of $93,855,000, a significant increase compared to the same period in the previous year. The company’s product sales during the quarter were $82,324,000, primarily related to the delivery of its COVID-19 vaccine to various markets. Royalties and other revenue, which include license fees and Matrix-M™ adjuvant sales, contributed $11,531,000 to the company’s top line.

Novavax’s cost of sales for the first quarter of 2024 was $59,209,000, which included expenses related to excess, obsolete, or expired inventory, as well as unutilized manufacturing capacity. The company’s research and development expenses for the quarter were $92,679,000, while selling, general, and administrative expenses were $86,798,000.

Liquidity

As of March 31, 2024, Novavax had $495,936,000 in cash, cash equivalents, and restricted cash, compared to $583,810,000 as of December 31, 2023. The company’s cash position has been supported by upfront payments under its advance purchase agreements (APAs), revenue from product sales, and royalties under licensing arrangements with its strategic partners.

Novavax has entered into various supply agreements, sometimes referred to as APAs, with governments and organizations globally. As of March 31, 2024, the aggregate amount of the transaction price allocated to performance obligations that were unsatisfied (or partially unsatisfied), excluding amounts related to sales-based royalties, was approximately $2 billion, of which $1.1 billion was included in Deferred revenue on the company’s consolidated balance sheet.

Failure to timely meet regulatory milestones, obtain timely supportive recommendations from governmental advisory committees, or achieve product volume or delivery timing obligations under Novavax’s APAs may require the company to refund portions of upfront or other payments or result in reduced future payments, which could adversely impact its ability to realize revenue from its unsatisfied performance obligations.

Regulatory Approvals and Pipeline Advancement

Novavax has made significant progress in obtaining regulatory approvals for its COVID-19 vaccine. The company’s updated vaccine, NVX-CoV2601, has received authorization from the U.S. FDA, the European Commission, the WHO, and several other countries globally. The company is also continuing to progress its regulatory authorizations for its prototype vaccine, NVX-CoV2373, in select territories, as it believes these may facilitate authorization of its vaccine candidates for updated strains in the future.

Beyond its COVID-19 vaccine, Novavax’s clinical pipeline includes a CIC vaccine candidate and a seasonal influenza vaccine candidate. The company has previously received agreement with the U.S. FDA on a Phase 3 design for its CIC vaccine, and it remains on track to submit an investigational new drug application and initiate the study in the second half of 2024, with potential accelerated approval and launch of the CIC vaccine in the fall of 2026.

Novavax is also advancing the development of its stand-alone influenza vaccine candidate. The company has generated positive data through its previous Phase 2 trial and expects to confirm and expand on these findings in the planned Phase 3 trial. Novavax believes this asset may also be attractive from a pandemic preparedness perspective, with the potential for similar performance in terms of comparative immunogenicity for A/H5N1 pandemic strains.

Sanofi Partnership and Strategic Pivot

In May 2024, Novavax announced a global co-development and co-commercialization agreement with Sanofi Pasteur Inc. This agreement is a significant milestone for the company, as it provides a multibillion-dollar opportunity over time and enables Novavax to pivot to a new growth strategy and a more lean operating model.

The key highlights of the Sanofi agreement include:

1. Upfront and near-term milestones of approximately $1.3 billion in cash, providing Novavax with a significant capital infusion to manage its business and remove the going concern status.

2. Beginning in 2025, Sanofi will leverage its global leadership in the vaccine business to commercialize Nuvaxovid in the U.S., U.K., and Europe initially, and worldwide over time, enabling Novavax to drive toward a new, more lean operating model with total costs anticipated to be well below its prior stated cost reduction targets.

3. Novavax will receive royalties and milestones from Sanofi’s efforts with Nuvaxovid, which are expected to exceed the value of what Novavax’s own efforts might have yielded.

4. Novavax has licensed Sanofi to use its Nuvaxovid to develop their own combination flu and COVID products, as well as to use Matrix-M as a component of other vaccines across Sanofi’s portfolio, which is expected to generate substantial additional royalties and milestones.

5. Novavax retains the ability to broaden and accelerate the development of its own wholly owned pipeline, including the modification of its planned 2024 pivotal trial for its CIC vaccine candidate to also include the potential to yield pivotal results for its stand-alone flu vaccine.

This transformative partnership with Sanofi validates Novavax’s product development capability and the extraordinary value of its Matrix-M adjuvant technology, potentially enhancing the company’s future licensing and business development opportunities across its technology platform.

Risks and Challenges

While Novavax has made significant strides in its vaccine development and commercialization efforts, the company faces several risks and challenges that investors should be aware of:

1. Regulatory Approvals: Novavax may not succeed in obtaining full U.S. FDA licensure or foreign regulatory approvals necessary to sell its vaccine candidates, which could have a negative impact on its ability to successfully market and commercialize its products.

2. Supply Agreements and Advance Purchase Agreements: Novavax’s existing funding and supply agreements or its advance purchase agreements do not assure the success of its vaccine candidates or vaccines, and if the company is unable to satisfy the performance obligations under such agreements, the agreements may be terminated, the purchase commitments may be reduced, or the company may be required to refund advance payments.

3. Manufacturing and Supply Chain Challenges: Novavax is significantly dependent on its supply agreement with Serum Institute of India Pvt. Ltd. and its subsidiary, Serum Life Sciences Limited, for co-formulation and filling (other than in Europe), and on its service agreement with PCI Pharma Services for finishing in Europe. Any delays or disruptions in these suppliers’ operations could prevent or delay the delivery of customer orders.

4. Competitive Landscape: Novavax faces competition from other vaccine manufacturers, including those with more established products and larger financial resources, which could impact the company’s ability to maintain or increase its market share.

5. Liquidity and Capital Requirements: Novavax’s future capital requirements depend on numerous factors, including its ability to generate revenue from product sales, milestone payments, royalties, and reimbursements under licensing arrangements with its strategic partners. The company’s ability to continue as a going concern is subject to its success in executing its business plan and securing additional funding as needed.

Outlook

Novavax’s partnership with Sanofi represents a transformative event for the company, providing a significant capital infusion, cost synergies, and the opportunity to leverage Sanofi’s global leadership in the vaccine market. This agreement, combined with Novavax’s robust pipeline of vaccine candidates and its innovative technology platform, positions the company for long-term growth and value creation.
As Novavax transitions to a more lean and agile operating model, the company is poised to accelerate the development of its own wholly owned pipeline, including its CIC and stand-alone influenza vaccine candidates, as well as explore new early-stage opportunities that leverage its Matrix-M™ adjuvant and nanoparticle technology.

Conclusion

With a strong balance sheet, a streamlined cost structure, and the backing of a global industry leader in Sanofi, Novavax is well-positioned to capitalize on the growing demand for effective and safe vaccines, delivering long-term value to its shareholders and contributing to improved global health.

Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.

[JoeForkeyBolo]

Novavax to Host Conference Call to Discuss Second Quarter 2024 Financial Results and Operational Highlights on August 8, 2024

https://ir.novavax.com/press-releases/2024-08-01-Novavax-to-Host-Conference-Call-to-Discuss-Second-Quarter-2024-Financial-Results-and-Operational-Highlights-on-August-8,-2024

[JoeForkeyBolo]

Added another 160 NVAX shares this morning. Average price now slightly higher at $5.62.

[JoeForkeyBolo]

Just picked up a few more shares at $13.87. Have $100K invested in NVAX at average share price of $5.52.

[mick]

NVAX
Novavax Inc
15.00
-0.85 (-5.36%)
Volume: 6,489,669
Day Range: 14.88 - 16.89
Last Trade Time: 2:24:24 PM EDT

[JoeForkeyBolo]

State Street Corp reduces NVAX holdings by 10M shares, and concurrently % of shares shorted drops substantially. Today share price rises 8.5% on fairly heavy volume. News leak? Shorts following lead of their big dog shorter and covering their positions? Start of massive short squeeze?

FDA approval for Fall 2024 Covid vaccine due any day now.

18K shares at $5.46 average price. Holding until I see multiple big biotech partnerships and eventual buy-out. 😎. Matrix-M adjuvant is a game-changer in the vaccine world. Glad to see Novavax returning to their best game of research and development of the best vaccine technology available.

[JoeForkeyBolo]

NEWS: Novavax Submits Application to Health Canada for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine

https://ir.novavax.com/press-releases/2024-07-02-Novavax-Submits-Application-to-Health-Canada-for-Updated-Protein-based-2024-2025-Formula-COVID-19-Vaccine

[JoeForkeyBolo]

NEWS: U.S. ACIP Recommends Use of Authorized and Approved 2024-2025 COVID-19 Vaccines

https://ir.novavax.com/press-releases/U-S-ACIP-Recommends-Use-of-Authorized-and-Approved-2024-2025-COVID-19-Vaccines

June 27, 2024

Today the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of a universal recommendation for the use of 2024-2025 COVID-19 vaccines authorized under Emergency Use Authorization (EUA) or approved by Biologics License Application in individuals aged six months and older.

Novavax intends to provide doses of our 2024-2025 COVID-19 vaccine at the start of the vaccination season and upon EUA by the U.S. Food and Drug Administration (FDA). When authorized, our vaccine will be the only protein-based option available in the U.S. for individuals aged 12 and older. Non-clinical data has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including JN.1, KP.2 and KP.3, indicating the potential to protect against future-drift JN.1 lineage strains.1,2 Recent public statements made by the FDA indicate that there will be no preference between JN.1 or KP.2 compositions, and both will be referred to as the 2024-2025 Formula.3

Having vaccine options is one way to potentially increase COVID-19 vaccination rates among individuals who have ceased to seek vaccination for a variety of reasons.4,5 We are working with global regulatory authorities to ensure access to our vaccine and have filed for authorization with both the U.S. FDA and the European Medicines Agency.

Use of the updated Novavax COVID-19 Vaccine, Adjuvanted in the U.S.

The updated version of the Novavax COVID-19 Vaccine, Adjuvanted targeting the JN.1 strain is currently under review by the U.S. FDA for EUA to prevent COVID-19 in individuals aged 12 and older.

[JoeForkeyBolo]

Novavax’s outgoing R&D lead says future will be different for Maryland biotech

June 26, 2024

https://www.bizjournals.com/washington/news/2024/06/26/novavax-filip-dubovsky-covid-vaccine-pandemic.html

Novavax outgoing R&D head Filip Dubovsky reflects on 4 years with vaccine maker.

Dr. Filip Dubovsky was the first person to see the clinical results from Novavax’s initial Covid-19 vaccine study in 2020.

The company’s chief medical officer looked at the data on his screen — just raw numbers. He didn’t need any graphs or charts to illustrate what he already knew. He charged down the hall to tell then-CEO Stan Erck and Dr. Greg Glenn, the company’s research and development lead at the time: “Guys, we have a vaccine.”

“I’ve been at this my entire career, all I’ve done is develop vaccines — and I’ve certainly had many, many more failures than successes,” Dubovsky told me. “You can generally tell when you look at those immune responses if you have a winner or not, and there was no doubt in my mind that we had a winner the very first time I saw that data.”

Dubovsky, 59, joined Novavax (NASDAQ: NVAX) that year, as the local biotech, still licking its wounds from a near collapse, entered the race in earnest to develop a coronavirus vaccine. Until then, the Gaithersburg company had been direct competition with Dubovsky, who was at AstraZeneca, in the RSV space. But Novavax’s technology was too attractive to pass up, he said.

Dubovsky was Novavax’s chief medical officer, then became president of R&D after Glenn retired — and through that time was instrumental in the company’s voyage to get its shot to the public.

He’s stepping away now because his wife took early retirement “and there was no way in the world I was going to let her start that journey without me,” he said with a laugh. They moved to Miami Beach last month and are preparing to become nomadic, as he describes it: first traveling to Europe, then setting out on a 5,000-mile driving tour through northern Canada in their SUV.

He’ll remain an adviser to Novavax’s team — remotely — as well as a shareholder with equity input.

But his departure also makes sense, he said, because Novavax’s recent deal with Sanofi to commercialize its Covid vaccine “actually de-risked the entire game of getting this technology pushed out there,” he said, noting that up to this point, “there was uncertainty whether the company would have the wherewithal to do it.”

Dr. Filip Dubovsky is stepping away from Novavax, after a critical four years with the company.

Novavax can now shift its focus back to its R&D roots and away from commercialization.

“The company going forward is going to be very different from the one that we have right now,” Dubovsky said, reinforcing a sentiment CEO John Jacobs has conveyed since striking the Sanofi deal. “We don’t need to be spending our resources on the commercial side; we do need to be spending our resources on expanding our pipeline and developing our technology.”

Novavax is still deciding what its new structure will look like, and whether it’ll tap someone to succeed Dubovsky in the same position, or “rejig it a bit,” as he put it.

But one thing that’s clear, he said, is that Novavax’s Matrix-M adjuvant — the immune-boosting secret sauce in its Covid vaccine — can be used for much more than that.

It’s already baked into a seasonal influenza vaccine and Covid-flu combination vaccine that Novavax is testing, as well as a malaria vaccine now shipping to countries in Africa. That’s a product that only drives small revenue for the company, but uses its technology to help save kids’ lives — ironic, after Dubovsky started his career in malaria vaccines, he said. And “that’s just the tip of the iceberg,” he added.

Going forward, Novavax could dive back into the RSV arena, or develop a vaccine for bird flu — which Novavax is now exploring with the U.S. government “because it would be the obvious purchaser for such a vaccine,” Dubovsky said.

Here’s more from my conversation with Dubovsky about his four years with Novavax — about the early days, the highs and lows, and the future.

What were your first months like at Novavax, at the height of the health crisis?
Remember, those were the dark days — people weren’t allowed to come in to work. In our buildings, there were maybe four of us that would come in regularly to work. And those were very long hours, seven days a week for two years. It was also extremely engaging, because we were the underdogs. We were playing in the Super Bowl, the Stanley Cup and the Kentucky Derby all at once.

Why was that work exciting for you?
I knew the technology had promise, that it would work. We just had to get it through the hoop. And eventually we did. In a sense, the licenses we’ve gotten globally, and the use we’ve had with millions of doses, has really validated the technology. And now there’s a wide-open field that this tech can be used in.

What does the Sanofi deal mean for Novavax?
There’s no reason this technology can’t be applied to the entire portfolio of vaccines going forward. And that’s what the company hopes to do. The money we’re getting from Sanofi — we’ll be able to do that, because now we’re finally in the financial position to stabilize the company, which is stabilized, but actually start growing the portfolio.

Novavax has had some high highs and low lows. What have been the biggest challenges?
There’s no denying we were late to the party. And as far as getting our vaccine licensed — we did something that no one’s ever done before: We got licensed in a couple of years. Unfortunately, Pfizer and Moderna did it in a year and a half. And that means that they got the financial rewards from it. There were a lot of concerns about pushing forward. This company had never manufactured a commercial vaccine before, and that turned out to be a real issue.

What has the impact been?
Our vaccine is a complex biological product. That has a different regulatory path and different regulatory requirements than the mRNA vaccines. That’s why we paid the time penalty. In the end — it’s validated, it’s fully licensed in many places, it’s authorized in the U.S. And certainly, the Sanofi partnership shows the technology is developable.

What’s one standout moment as you look back?
In the early days, all the governments and people were very anxious to get a product. We would get calls from world leaders and governments on a routine basis, seeing when our vaccine would be ready, when they could access it. And that was very new for me. That was, personally, slightly intimidating for me, but also, kind of fun — because it showed the value of science, it showed society and governments and leaders really valuing science, which is something I’m a huge believer in. So it kind of validated my existence. The world was paying attention to vaccines.

[JoeForkeyBolo]

NEWS: Novavax Submits Application to European Medicines Agency for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine

https://ir.novavax.com/press-releases/2024-06-24-Novavax-Submits-Application-to-European-Medicines-Agency-for-Updated-Protein-based-2024-2025-Formula-COVID-19-Vaccine

[JoeForkeyBolo]

Added more NVAX shares today, bringing average share price a bit higher to $5.46.

[JoeForkeyBolo]

Novavax's New Vaccine Just Changed the Game—non-mRNA Solution

June 21, 2024
https://www.guerillastocktrading.com/novavaxs-new-vaccine-just-changed-the-game-non-mrna-solution-💉/

[JoeForkeyBolo]

Added more NVAX shares on the dip today, bringing average share price a bit higher to $5.37, with 96.3% of my shares purchased prior to Sanofi partnership. 😎

Expecting to make an absolute killing on this stock over the next few years. Thanks to GC for turning me onto Novavax.

[chrismiss_everyday]

https://ir.novavax.com/press-releases/2024-06-14-Novavax-Submits-Application-to-U-S-FDA-for-Updated-Protein-based-2024-2025-Formula-COVID-19-Vaccine

[JoeForkeyBolo]

Novavax, Inc. (NASDAQ:NVAX) has caught the attention of institutional investors who hold a sizeable 49% stake

SimplyWallStreet.com
June 10, 2024

https://finance.yahoo.com/news/novavax-inc-nasdaq-nvax-caught-121817276.html

[JoeForkeyBolo]

Investors Heavily Search Novavax, Inc. (NVAX): Here is What You Need to Know

Zacks Equity Research
June 10, 2024

https://finance.yahoo.com/news/investors-heavily-search-novavax-inc-130016966.html

[JoeForkeyBolo]

The Motley Fool: Bull Market and Beyond: 3 Stocks Just Waiting to Soar
June 11, 2024

https://www.fool.com/investing/2024/06/11/bull-market-and-beyond-3-stocks-that-may-soar/

Novavax is listed as #1 stock.

[JoeForkeyBolo]

Annual Shareholders Meeting to be held Thursday, June 13, 2024 @ 08:30 a.m. Eastern. Links below.

2024 Proxy Statement

Virtual Shareholder Meeting

[JoeForkeyBolo]

Link to transcript of Novavax Jeffries 2024 Global Healthcare Conference

https://stkt.co/M9gyc5AQ

Worth reviewing the call again in transcript format. Transcripts give one the ability to search for specific items or keywords. Enjoy!!

[JoeForkeyBolo]

BREAKING: 9th Circuit Court of Appeals Rules mRNA COVID-19 Jab is NOT a Vaccine Under Traditional Medical Definitions
by Jim Hoft
June 8, 2024

https://www.thegatewaypundit.com/2024/06/breaking-9th-circuit-court-appeals-rules-mrna-covid/

The United States Court of Appeals for the Ninth Circuit has delivered a seismic decision that could reshape public health policy across the nation.

In a contentious case involving the Health Freedom Defense Fund and other plaintiffs versus the Los Angeles Unified School District (LAUSD), the court has declared that mRNA COVID-19 injections do not qualify as vaccines under traditional medical definitions.

The case revolved around the LAUSD’s COVID-19 vaccination policy, which required all employees to be fully vaccinated against COVID-19 by a specified deadline.

The plaintiffs argued that the district’s vaccine mandate infringed upon their fundamental right to refuse medical treatment, as the mRNA injections do not prevent the transmission of COVID-19 but merely mitigate symptoms for the recipient.

The court’s opinion, penned by Circuit Judge R. Nelson and supported by Judge Collins, asserts that the mRNA shots, marketed as vaccines, do not effectively prevent the transmission of COVID-19 but merely reduce symptoms in those who contract the virus. This crucial distinction undermines the foundational premise of the vaccine mandates enforced by various governmental and educational institutions.

Judge Nelson pointed out that the mandate was inconsistent with the Supreme Court’s century-old ruling in Jacobson v. Massachusetts, a case that upheld the state’s right to enforce smallpox vaccinations due to their proven effectiveness in preventing disease spread. In contrast, the mRNA COVID-19 shots do not offer such public health benefits, thus failing the criteria established by Jacobson.

The ruling points out that traditional vaccines are designed to provide immunity and prevent transmission, which is not conclusively proven in the case of mRNA COVID-19 shots.

The Gateway Pundit previously reported that the Centers for Disease Control and Prevention (CDC) had modified the definition of “vaccine” to include the mRNA shots.

So, look at what the CDC did. Here’s the definition the CDC used on 26 August 2021:

• Vaccine– “a product that stimulates a person’s immune system to produce immunity to a specific disease.”
• Vaccination– “the act of introducing a vaccine into the body to produce immunity to a specific disease.”

Rather than admit the COVID-19 vaccine is not working as advertised, the CDC took a page out of Orwell’s 1984 and opted for new spin language.

Here is the new definition:

• Vaccine– “a preparation that is used to stimulate the body’s immune response against diseases.”

It can be recalled that Pfizer’s President of International Developed Markets, Janine Small, admitted in an EU hearing that the vaccine had never been tested on its ability to prevent transmission, contrary to what was previously advertised.

Judge Collins, in a concurring opinion, highlighted that compulsory medical treatments for individual health benefits infringe upon the fundamental right to refuse such treatments. This perspective aligns with the constitutional principles protecting personal liberty against unwarranted governmental intrusions.

You can read the full ruling at the link below:

Ruling No. 22-55908

[JoeForkeyBolo]

NEWS: Novavax gets grant for vaccine for treating or preventing c. difficile bacterial infection

https://www.pharmaceutical-technology.com/data-insights/novavax-gets-grant-for-vaccine-for-treating-or-preventing-c-difficile-bacterial-infection/?cf-view

June 7, 2024

Novavax has developed a vaccine composition to treat or prevent C. difficile infection. The multivalent immunogenic polypeptide contains portions of multiple toxins from bacteria, inducing effective immune responses. The patent aims to provide innovative methods for combating bacterial infections.

According to GlobalData’s company profile on Novavax, Anti-RSV vaccines was a key innovation area identified from patents. Novavax's grant share as of April 2024 was 41%. Grant share is based on the ratio of number of grants to total number of patents.

A recently granted patent (Publication Number: US11938179B2) discloses a multivalent immunogenic polypeptide designed to target Clostridium difficile infections. The polypeptide consists of a binary toxin (CDT) portion, a Toxin A portion, and two Toxin B portions, each derived from a C. difficile toxin protein. The patent specifies the amino acid sequences for each portion, emphasizing a high degree of homology to specific sequences (at least 90%, 95%, 97%, 98%, or 99% homology). The arrangement of the portions, with the Toxin A portion positioned between the two Toxin B portions, and the presence of specific amino acid linkers between them, are also detailed in the claims.

Moreover, the patent covers a nucleic acid molecule encoding the polypeptide, along with a method for its preparation involving expression in an insect host cell and isolation using a non-ionic detergent. An immunogenic composition comprising the polypeptide and a suitable carrier, excipient, or diluent is also described, with the inclusion of an adjuvant, particularly a saponin-based adjuvant containing specific fractions in defined proportions. This patent highlights a novel approach to developing an immunogenic polypeptide targeting C. difficile infections, with a focus on specific amino acid sequences, arrangement, and production methods, offering potential advancements in combating this challenging medical condition.

[JoeForkeyBolo]

Comments on today's conference presentation by Alexis on Yahoo.

Some notes on today's discussion at the Jefferies Global Healthcare Conference:

• In market in August with "ample supply" of EUA authorized JN.1 pre-filled single-dose syringe

• People don't "shop" for vaccines by brand, "major levers of adoption" determined by retail availability

• 90% of last years administered doses were in the retail channel, caught NVAX by surprise

• 40-50% of 2023 demand occurred in the first four weeks of the campaign

• No updates to revenue guidance despite the JN.1-lineage VRBPAC recommendation

• Can't "opine in detail" about ongoing discussions with Sanofi; deal has four layers of value

• Cash flow from the Sanofi agreement will "exceed what we could have done ourselves"

• "We have our own late-stage pipeline", looking at investing in early-stage product development while pursuing additional partnerships

• "Matrix-M has ability to help lower partners' COGS through reduced antigen load and improved immunogenicity"

• Any news on Sanofi's flu vaccine development? "They have big plans" but not willing to share any details. The transaction with NVAX "speaks for itself"

• Lots of confidence of Phase 3 programs for flu-covid combination based off Phase 2 results, following accelerated pathway for both flu and combo authorization in 2H next year

• "We assume we'll have success" with Phase 3 and will have options to sell/license/partner to compete in multi-billion dollar marketplaces, whether they're first to market or not (for combo)

• Building "lean" organization and focusing on pipeline

[Docsavag]

Thanks, done.

[JoeForkeyBolo]

Go ahead, just mention the poster on ST. My Yahoo login was cancelled from lack of use.

[Docsavag]

Can you please share this on Yahoo Finance board, or mind if I do?

[JoeForkeyBolo]

Good summary of today's conference call posted by dennissan on ST. I was on the call and agree 100%. The oncology mention was new info. I am extremely bullish on future of Novavax. 👍️

Todays, Jefferies Global Healthcare Conference talking points.
Very optimistic atmosphere, and not trying to be over confident'
1, Many companies will be licensing the adjunct for very applications including Oncology as well. Huge.
2, NVAX’s two Phase 3 covid/flu shot and stand-alone flu shot ready for market by 2025. Huge
2, Global Leader, SNY w/ 100 Billion Market Cap has a 5% stake in NVAX, and 700M more incentives and will be helping commercialize and promote NVAX products asap. Look for Commercial promotions and applications. Very Huge
3, Any new Vaccine that SNY uses NVAX adjunct cost’ 200M upfront and royalties
Ready fro lift off..
BTW, Murdorna has more than 2 X's as many share outstanding at 338M??

[john1311]

many thanks....

[john1311]

Congrats. Love to see wealth creation. Hopes you enjoy your smart trading and good fortune.

[JoeForkeyBolo]

Link to video of FDA Vaccine and Related Biological Products Advisory Committee Meeting held on June 5, 2024.

Novavax Chief Medical Officer, Dr. Robert Walker, begins his 18-minute presentation to the committee at 3:21:15 in the video, where he provides the data supporting Novavax's decision to begin manufacturing of the JN.1 vaccine, and why this will be effective for KP.2/KP.3 and all sub variants of the JN.1 lineage. A lot of technical detail is given, but it's worth it to muddle through because by the end of the presentation it is clear, even to the layman, that their JN.1 approach and recommendation to the committee was effective in helping steer the committee to identifying JN.1 as their recommendation. Overall an excellent presentation by Novavax.

[JoeForkeyBolo]

Link to 2024 Jeffries Global Healthcare Conference. Registration is required, but you can use any name and email address ( i.e., Johnny Peckerhead / Fake Analyst / [e-mail]) if you want to keep yours off their marketing email list. Novavax presentation begins at 12:30 Eastern.

Should be time well spent. Audio will be available on Novavax website for 30 days following conference. Click Virtual webcast to access the site.

https://ir.novavax.com/events#nav

[JoeForkeyBolo]

First-gen mRNA flu vaccines 'will not win,' Sanofi execs admit as they retool strategy

FIERCE Biotech
June 30, 2023

https://www.fiercebiotech.com/biotech/first-gen-mrna-flu-vaccines-wont-win-sanofi-execs-admit-they-retool-strategy

Interesting read. This explains why they partnered with Novavax for Matrix-M. I expect we will see additional partnerships for Matrix-M announced with other biotechs in the coming months.

$ $ $

[JoeForkeyBolo]

NEWS: Novavax Prepared to Deliver JN.1 Protein-based Non-mRNA COVID-19 Vaccine This Fall Consistent with U.S. FDA VRBPAC Recommendation

https://ir.novavax.com/press-releases/Novavax-Prepared-to-Deliver-JN-1-Protein-based-Non-mRNA-COVID-19-Vaccine-This-Fall-Consistent-with-U-S-FDA-VRBPAC-Recommendation

June 5, 2024

Today the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend that COVID-19 vaccines be updated to a monovalent JN.1-lineage composition for 2024-2025 and expressed a preference for the JN.1 strain. The Committee acknowledged the importance of having a protein-based option available at the start of the vaccination season, alongside other alternatives. Novavax expects to be ready for the commercial delivery of a protein-based JN.1 COVID-19 vaccine in the U.S. in September this fall, pending authorization.

The Committee acknowledged the advantages of a JN.1 vaccine in providing broad protection against circulating and future strains, based upon data presented by all manufacturers, and the need to minimize confusion in making public health recommendations. Novavax’s JN.1 COVID-19 vaccine has demonstrated broad cross-neutralizing antibodies for a range of JN.1 descendant viruses, including KP.2 and KP.3. We believe updating to the JN.1 lineage or JN.1, as recommended by the World Health Organization and the European Medicines Agency and as unanimously recommended by VRBPAC today, will provide the protection needed this fall against COVID-19.1,2

Our most recent nonclinical data have demonstrated that our JN.1 vaccine candidate induces broad neutralization responses to JN.1 lineage viruses including those with the F456L mutation (e.g., JN.1.16), the R346T mutation (e.g., JN.1.13.1), to “FLiRT” variants that contain both mutations such as KP.2, currently the most common circulating variant in the U.S., and to “FLuQE” variants that are increasing in circulation (e.g., KP.3).1,3,4 Our JN.1 vaccine candidate also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants including those containing the F456L, R346T and FLiRT mutations (e.g., KP.2).1 These responses indicate that our vaccine technology induces broadly neutralizing responses against multiple variant strains, including to circulating forward drift variants.

[tbonaces80]

Sold. 100k. Thank u

[mick]

NVAX
Novavax Inc
14.99
-0.12 (-0.79%)
Volume: 4,253,008
Day Range: 14.71 - 15.45
Last Trade Time: 12:17:17 PM EDT

[AMA]

Looks ripe!