Novavax Inc (NVAX)

[LUCKYBUTT]

Myocarditis is inflammation of the heart muscle, called the myocardium. The condition can reduce the heart's ability to pump blood. Myocarditis can cause chest pain, shortness of breath, and rapid or irregular heartbeats. Get another jab lol. Guess you're a big Taylor Swift fan too. LMAO

[JoeForkeyBolo]

CNET – Move Over, mRNA: What to Know About the Novavax COVID Vaccine

https://www.cnet.com/health/medical/move-over-mrna-what-to-know-about-the-novavax-covid-vaccine/

[JoeForkeyBolo]

I'll be sure to let Sanofi know they made a huge mistake in partnering and investing $1.3B in Novavax. I'm sorry they failed to consult you for your thoughts as part of their due diligence. Most likely they elected to ignore those who have no knowledge about Novavax, their current and forthcoming product lines, and the value of their Matrix-M adjuvant to other pharma companies.

But thanks for the entertainment.



Currently have over $146K in profit here. I'm buying more NVAX shares this week.

[LUCKYBUTT]

covid is over. Good luck catching MONEY POX with these vax. Stop the P&D's please. This is a P&D stock

[JoeForkeyBolo]

Here's an interesting data point on Novavax vaccine posted on Yahoo and Stocktwits NVAX forums.

I just spoke at Costco with 2 pharmacists, they said out of all people getting vaccinated, over 50% chose NVAX.
And less than 50% getting Pfizer and Moderna. I was at Costco at 973 3rd Avenue, Brooklyn, NY.
Go there or call to confirm, if don’t believe me. NVAX 🚀 🚀 🚀

I've also read numerous messages from investors trying to locate in-stock Novavax vaccines, where pharmacies are reporting they are already sold out of their initial shipments and are awaiting resupply. Our vaccine seems to be in high demand among those choosing to get vaccinated. 👍️

But, sadly, I've also read numerous messages where the pharmacies had never heard of Novavax and were unaware they had it in stock until the customer asked them to check. For some who knew of Novavax, they didn't understand the difference between Novavax and mRNA vaccines.

[JoeForkeyBolo]

THE TURNAROUND MAN – John Jacobs is reshaping Novavax for the post-pandemic era



https://www.bizjournals.com/washington/news/2024/09/26/novavax-john-jacobs-vaccines-covid-flu.html

Access to the article at the link above requires a subscription.

Use this link to download the PDF of the article – 6 pages in length
PDF Link

Use this link to download the MP3 audio of the article – 13 minutes in length
MP3 Link

[JoeForkeyBolo]

You should look up the definition of P&D as you are clearly uninformed. If you need someone to teach you how to use Google, let us know. Or perhaps you can use that new search engine being pumped over on the MONI site. I hope you haven't bought into that garbage. Those guys haven't made any real progress in the past and MONI is just another means to continue lining their pockets with investor money, IMO.

Did you see where I sold part of my NVAX holdings on the latest news and bought back $1.50 lower and gained $9,425 worth of FREE Novavax shares? Lowered my average cost basis from $5.63/share to $5.41 in the process. That's what some claim to be doing on the MONI board. So how are their actions not a P&D but mine are?

Novavax has a short-seller problem. The overall percentage of shares shorted has been heading lower for months, currently around 20-22% of outstanding shares. I don't short stocks and I don't buy on margin. Myself and some other NVAX investors are trying to take advantage of shorting presence by trading a little on the price swings created by these shorts. That's not illegal, and it's not pumping and dumping as you seem to believe. My outlook on Novavax has always been positive, and my outlook doesn't change on a dime like it does with most P&D'ers. Look to your own MONI board for examples.

Educate yourself more and you won't appear uninformed or ignorant in what you post. I'm guessing you don't really care. 🤣

[JoeForkeyBolo]

For those investors who are unhappy with CEO Jacobs and particularly his lack of publicly addressing short sellers, travel back in time to this June 2023 podcast interview with Jacobs. Interview starts at 16:15 and is worth a listen.

Remember this was 10 months prior to the Sanofi deal and while the "going concern" statement in the filings was a major issue with the company. I think it helps put things in perspective a year later. More great things ahead for Novavax, in my opinion. I'm happy to be invested here.

[LUCKYBUTT]

HERE IS WHERE JOEFUNKY RUNS ANOTHER P&D

[JoeForkeyBolo]

I completed swing trades of NVAX in my 4 Fidelity accounts and picked up 754 free shares today. I added 37 free shares last Friday on much smaller trades. The free shares has lowered my average cost per share from $5.65 to $5.41. I've grown tired of the short-sellers killing the share price with any decent run-up so I decided to try to take advantage. I don't think this opportunity will last much longer with the news expected in the coming weeks and months. Shorts will eventually move on.

[JoeForkeyBolo]

NEWS: Novavax Names Dr. Ruxandra Draghia-Akli as New Executive Vice President and Head of Research & Development

https://ir.novavax.com/press-releases/2024-09-25-Novavax-Names-Dr-Ruxandra-Draghia-Akli-as-New-Executive-Vice-President-and-Head-of-Research-Development

[JoeForkeyBolo]

I've seen a lot of buyout numbers posted on other sites. I believe $50 is too low, although it seems like a good price compared to current share price. However, the new business model for creating great technology and licensing it to BP partners is just getting started. According to CEO Jacobs and other company execs speaking on numerous conference calls or presentations, they plan on licensing the Matrix-M adjuvant to others and stated there is significant interest. That tells me other partnerships are likely forthcoming, similar to the Sanofi deal.

In determining a fair buyout price that would be accepted, they would need to factor in not only the expected revenues from the Sanofi partnership, but the revenues other partners might bring over the next 5-10 years, adjusted for current valuation. My gut tells me that is far above $50/share and $100+ is more likely. While many shareholders might be willing to accept a $50 offer, I don't think the company would settle for such a low value with the revenue the new business model and the company IP would be expected to bring in the coming years.

My hope for Novavax is they partner with several BP's and when the time comes for a buyout offer, a bidding war ensues. 😎

[EternalPatience]

What are the odds of sanofi buying them out for a healthy premium, say 50$?that would cause a short squeeze of epic proportions

[EternalPatience]

Patiently waiting

Eternally waiting

Eternally patient

[JoeForkeyBolo]

On the hunt for Novavax: Why people are seeking out the 'traditional' COVID vaccine

https://www.yahoo.com/lifestyle/on-the-hunt-for-novavax-why-people-are-seeking-out-the-traditional-covid-vaccine-192105984.html

[JoeForkeyBolo]

Sanofi CEO believes company poised for growth from new drugs

https://www.reuters.com/business/healthcare-pharmaceuticals/sanofi-ceo-still-considering-how-split-consumer-biz-hopes-keep-stake-2024-09-23/

I feel confident the licensing of the Matrix-M adjuvant from Novavax has a lot to do with this expected growth. 😎

[JoeForkeyBolo]

Health Canada approves Novavax's updated COVID-19 vaccine for fall

https://www.cbc.ca/news/health/novavax-covid-vaccine-2024-2025-1.7328401

[JoeForkeyBolo]

I received the updated 2024-25 Novavax Covid vaccine this week at CVS. Other than minor soreness at the injection site and minor fatigue the next day, no side other effects to report. I received the Covid vaccine in one arm and the quadrivalent flu vaccine in the other arm, so the combined vaccines and not getting a full night's sleep the previous night probably contributed. I just slept a lot the following day recovered fine.

The pharmacy tech knew little about the non-mRNA Novavax vaccine, so I spent the time educating her a bit. The information peaked her interest and she stated she was going to research the vaccine more.

I'm looking forward to success of Novavax's Combined Influenza-Covid (CIC) vaccine and plan to get it every year once it completes testing and approval process. Matrix-M adjuvant will help it to succeed where others have failed.

[JoeForkeyBolo]

Advice from the Masters that will benefit Novavax investors.

[EternalPatience]

Fantastic. Thanks for the detailed reply

[JoeForkeyBolo]

I don't make price predictions. I do expect by end of 2024 the share price will be significantly higher than today, based on the updates management stated they will provide regarding new pipeline and strategy.

The major reason I invested in Novavax was the new CEO and his plan to change the business model. Sanofi involvement is huge and validates not only the new business model but their superior Matrix-M and Covid vaccine technologies. I expect other BP to partner in similar fashion, possibly another one added by end of 2024.

So with the new business model focused on their excellent R&D and creating new products that will be highly sought after by BP, I expect only two scenarios... both of which should greatly benefit investors.

1. Business model continues with new BP partnerships inked, resulting in billions in annual revenue growth over next several years.

2. Sanofi or one of the BP partners (or BP who hasn't partnered yet) will make offer to buy Novavax. Hopefully this creates bidding war over fear new owner won't license the Novavax technology acquired.

That's how I believe things will shape up and why I'm invested here. Sure, the short-term swings are frustrating, but I'm keeping my eye on the long goal and continuing to accumulate shares. I may start trading a portion of my holdings on any news as long as shorts continue to play their games as a means of picking up free shares.

I will state my expectations for either of these scenarios playing out is north of $100 per share, and I believe that is conservative. My cost basis is $5.65 with 93.5% of my shares purchased pre-Sanofi. GLTY

[EternalPatience]

What are your price predictions for end of 24, mid 2255 and mid 2026

[JoeForkeyBolo]

I don't think it will be stuck in this range forever. News coming in the fall should push it out of this range, and certainly the Covid-Influenza Combination vaccine trial results expected mid-2025 will move it higher, as they are expected to be excellent. Short interest has dropped and one of the largest shorters (State Street) has closed their short position. Those who continue to short this stock after the Sanofi deal are risking heavy losses, as more partnerships are expected and management has stated they are working towards that goal.

I have a sizable pre-Sanofi position and continue to accumulate shares at these prices.

[EternalPatience]

Stock price is stuck in low teens for ever though

[JoeForkeyBolo]

Why Novavax is Gaining Ground in COVID-19 Vaccine Race

https://finance.yahoo.com/news/why-novavax-gaining-ground-covid-220000070.html

[JoeForkeyBolo]

WARNING: Based on customer feedback on multiple message boards, numerous CVS locations have attempted to use the mRNA vaccine instead of the Novavax vaccine requested. Be sure to check the syringe to ensure it is the Novavax product. CVS has claimed it is a glitch in their computer system, but there have been walk-ins reported that were never in their appointment system and they still tried to administer the mRNA vaccine. It seems CVS is biased toward the mRNA vaccines and will only administer Novavax if requested (and sometimes not even then). The number of reported incidents leads me to think this is intentional. I won't be using CVS for this reason.

Be vigilant to ensure you're getting the vaccine you requested. Check the syringe. Novavax uses prefilled syringes for the 2024-2025 vaccine. This advice applies to any vaccine provider, not just CVS.

[JoeForkeyBolo]

Added more NVAX shares on the dip. Getting my Novavax Covid vaccine this week.

[Fiberman]

Finally, just made my appointment to get the updated Novavax COVID vaccine tomorrow at CVS.

[JoeForkeyBolo]

NEWS: Novavax 2024-2025 Formula COVID-19 Vaccine Available at Major Pharmacies Across the U.S.

https://ir.novavax.com/press-releases/2024-09-13-Novavax-2024-2025-Formula-COVID-19-Vaccine-Available-at-Major-Pharmacies-Across-the-U-S

[JoeForkeyBolo]

Novavax, Inc. (NVAX) H.C. Wainwright 26th Annual Global Investment Conference (Transcript)

Source: https://seekingalpha.com/article/4720037-novavax-inc-nvax-h-c-wainwright-26th-annual-global-investment-conference-transcript

Novavax, Inc. (NASDAQ:NVAX) H.C. Wainwright 26th Annual Global Investment Conference September 9, 2024 3:30 PM ET

Company Participants
Jim Kelly - CFO
Bob Walker - Head of R&D

Conference Call Participants
Vernon Bernardino - H.C. Wainwright

Vernon Bernardino

Okay. Good afternoon, everybody. Welcome to the 26th Annual H.C. Wainwright Global Investment Conference. Our next company presenting are -- that we're having a chat today is Novavax, company that by now, hopefully, all of you know really well. They have Nuvaxovid, which is one of three COVID vaccines that is in authorization or license for commercialization. One thing that I do want to highlight though is Nuvaxovid is the only protein-based vaccine that's in commercialization. The others are mRNA-based. With that, I think to begin, you mentioned in your fourth quarter annual results call that you have four drivers of the stock that you're focused on in the long term and then you also have near term drivers. Could you walk us through those four drivers and then what should we expect near term?

Jim Kelly

Absolutely. And I should first really thank you for having us again this year, Vernon here. I really appreciate you here having us here. And we've had just great meetings with investors who, given the time of year, the respiratory season and just of course, getting our COVID vaccine approved just at the end of August, so much interest. And so it's been great to be out with you. I'm joined by Bob Walker, Head of R&D. Jim Kelly, CFO. And you're exactly right. Four pillars to drive value, shareholder value for our company and especially in light of a transformative transaction, which was the Sanofi transaction we announced back in May, which is pillar number one, billions and billions of potential cash flow from that transaction. And most importantly, what they can do to take our technology and bring important vaccines to patients. So pillar number one, the Sanofi agreement. Pillar number two, our late stage pipeline. We have our own proprietary flu and a combination flu COVID vaccine that are going to read out mid next year. So that's the second pillar. Number three, is doing incremental business development deals with our Matrix platform. Again, so much value that can be created to either improve existing vaccines or create new. And then finally development of our own organic portfolio and much more on that later this year. We got a validated platform plan to do much more and we plan to do so with a lean operating platform as we continue to drive down costs, as we transition from being a commercial stage global company to one that is focused on R&D and developing value that way.

Question-and-Answer Session

Q - Vernon Bernardino

Yes. And you've been -- this is an initiative that was taken on by John Jacobs, who came on Board the beginning of last year.

Jim Kelly

That's right.

Vernon Bernardino

And so they're showing execution, which I think hasn't been totally appreciated. So let's focus briefly on the Sanofi deal. Can you tell us a little bit about the terms and opportunities it represents for you?

Jim Kelly

Well, certainly. And just in a moment before I hit that, I’d tell you what there couldn't have been more change in the last 20 odd months since John joined. I mean, I think you know it. He came in in January of 2023. And almost instantly, on that sort of end of February, early March call, mapped out strategic initiatives to transform the company. And we kind of sit here today well down that path and with humility, you're never all the way there but we're really pleased with the progress of the last you know 20 months. And one of the hallmarks, I think, of this change has been this transaction, which I'm happy to walk through in a lot more detail now. The Sanofi agreement that we announced back in May has multiple dimensions and that's why it takes a little more time to kind of be understood, inclusive of initial upfronts and milestones of the transaction itself. So $500 million upfront, a $70 million equity investment. And then you look at how milestones royalties are available to the company for both the COVID vaccine and Sanofi's ability to develop combination vaccines alongside our COVID. $700 million in milestones across both and then significant royalties across both those programs available to us. Then the fourth piece or another piece of significant value creation is Sanofi has value to our or access to our Matrix. So they can take our Matrix and apply it to their existing vaccines, all except their flu or develop new vaccines. And we've got the ability to receive up to $210 million in milestones per vaccine and receive royalties on vaccines where they put it together with our Matrix. So those royalties can go 20 years. So significant value creation across this transaction. But importantly, it was done with a market leader in respiratory vaccines. We couldn't have really chosen or scripted a better partner. And so we're thrilled with not just the terms but also who we're working with.

Vernon Bernardino

For those who don't know, I mean, Sanofi is obviously big in the vaccine space. You've probably seen commercials already by now that they market the seasonal flu vaccine Flublok and Fluzone. And so this is a company that you would want to partner with as far as the vaccine space is concerned. Because in their past, they've also acquired vaccine technology, Chiron. That's dating myself here. But you know I've known the company since 2004, so there's quite a bit of Wall Street here, my second career.

Jim Kelly

Well -- and of particular importance to us is that when you look at their portfolios of where they play in respiratory vaccines, they've got the highly innovative, highly differentiated programs that really match up well to how we develop vaccines. And so in particular, we look at the 65 plus group and just that tends to be the premium markets and the types of markets where we play. So that part worked as well.

Vernon Bernardino

Yes. And the 65 plus group is the one who usually generate the weakest immune responses to vaccines. So big pharma partners present there is going to be very advantageous and synergistic. One thing that I think is really not appreciated adequately is Matrix-M. Matrix-M is an adjuvant. Matrix-M is also a technology, as Jim said. Can you very briefly, I mean, a lot of people do know what an adjuvant is tell the audience what an adjuvant is and the various uses that perhaps Matrix-M could be expanded and adapted to?

Bob Walker

Sure. So Matrix-M is a saponin based adjuvant. Some people are familiar with the GSK product, ASO-1, also saponin based, which is an extract of a Chilean tree, of bark of a tree that grows in Chile. So it's an extract that is then combined with cholesterol and phospholipids and forms a substance that when administered along with, in our case, a nanoprotein antigen, boosts the immune response. And the type of boosting of the immune response that Matrix-M delivers is both on the humoral side. So the magnitude and the breadth of the antibody responses but also the T-cell responses, which we think gives Matrix an edge, and is one of the distinguishing factors that we see both with our COVID vaccine as well as our flu vaccine. Now we have looked at Matrix with other competing flu vaccine products that are currently not adjuvanted and produced in egg systems, and we see the same types of responses. So we think that we can potentially partner with other flu vaccine manufacturers if they're looking for an adjuvant or looking to, for example, induce a T-cell response, this might be a good adjuvant to think about. We've also looked at the ability for Matrix to boost non-viral antigens and specifically pneumococcal antigens. So pneumococcal vaccines are based on polysaccharides. Polysaccharides historically have been difficult to be immunogenic in the populations that need them the most, tend to be the extremes, the babies and the elderly. And when we combined a market leading pneumococcal vaccine with our Matrix in laboratory animals, we see the same kind of adjuvanticity.

So we think that Matrix-M has potential to boost other existing marketed vaccines. It has the ability potentially to to revisit certain antigens that have -- or certain infectious diseases where that have not been considered to be necessarily amenable to vaccines but potentially by revisiting the approach and combining with Matrix, you'll see a different -- different properties. And then I think there's the world beyond infectious diseases, which we're currently assessing. And I think that later towards the end of the year when we unveil what our new pipeline will look like and where we'll be going, I think that there will probably be some opportunities to look outside strictly infectious disease vaccines.

Vernon Bernardino

Now, what many investors may not know is those old protein vaccines that you used to take or still take that are protein based, often had an adjuvant in them called alum, which is a different or formulation of aluminum. So the idea is not new but Matrix-M is. And the basic idea is it boosts the immune response. But with Matrix-M, you perhaps have at least a 2x or many fold boost in that response. I think that's perhaps, let's see, by year end when you have the portfolio reveal how those opportunities are actually going to be best communicated and hopefully further appreciated.

Jim Kelly

Yes, I mean, you just reminded me. One of the other aspects is that the, what's called antigen-sparing property of adjuvant. So you can actually -- and that translates into better cost of goods, right? That's the point I was driving at. So if you can find the right adjuvant, you can actually lower your protein production costs, which is really where a lot of the money gets spent in manufacturing of vaccines. And so even -- you know anyway, there's other opportunities there to help folks -- other partners, for example, reduce cost of goods by looking at Matrix.

Vernon Bernardino

And the protein sparing also sort of has a little bit of quality of life aspect to it. Because can you imagine to get more immunogenicity you can also just inject more protein to get a higher response. But because of formulations that can actually be painful. And you know over time people may not get their vaccines or you know hesitate to finish a course, because it's just an injection is painful. So you imagine if you had a volume like I've had for a rabies when I got bit by a dog, you have this course of vaccines and those are huge volume injections. And so dose sparing is another aspect of the adjuvant technology you have that's underappreciated. Real quick on to CIC, which is the combination COVID seasonal influenza vaccine, positive Phase 2 results. Could you tell us a little bit about those plans and you know whether you're on track for the Phase 3 immunogenicity trials?

Jim Kelly

I'll take that one too. So yes, we're initiating a Phase 3 immunogenicity study, looking at both CIC and our standalone flu in the same Phase 3a study. And we're on track to start that in October of this year. And we're expecting our first data readout to be by mid 2025, and that's going to be a really important data readout for us, right? Because you know that's where going to see, it's gonna be very binary, we think. You know we either see non-inferiority to the market leader or we don't. And we're fully expecting that based on the Phase 2 data we are gonna see non-inferiority or not superiority, that's right. And that's going to, I think, open up the door to partnering discussions where we actually have an asset at that point that's been proven.

Jim Kelly

Really important because we're planning on investing up through these data readouts mid next year partnering and then we're seeking to have the partner advance the filing, run the Phase 3b, post marketing commitments and commercialize. And through that partnership have available upfronts, milestones and royalties as a part of continuing to monetize and create value from our pipeline.

Vernon Bernardino

Perfect. Now, as you remember that Jim mentioned earlier, one of the pillars that CEO, John Jacobs, had the company implement was getting costs under control, but yet it's a drug a, you know, a vaccine development company. So there's going to need to be spend. The results so far have been great. I think my model does expect you to at least be operationally breakeven sometime next year. I forget which quarter it is. But can you talk a little bit about those initiatives, efforts and the results you have so far?

Jim Kelly

Well, certainly. As folks heard when we started today, hey, we're a pandemic company and so we scaled up for this global reach to be able to deliver billion of doses. Well, we transitioned the company in the past few years to a post pandemic model, really cleaned up our balance sheet, cleaned up our OpEx and now are increasingly emphasizing our R&D roots. So what does that mean mathematically? Well, in 2022, we had $1.7 billion in R&D and SG&A. By 2026, we expect to have less than 350%, a 80% reduction. How the heck do you do that? Well, a lot of it is, hey, we worked our way through those operation warp speed studies. It was great, the government helped us, it was such a great help in investing in our COVID platform. Then as we move through this year and the next, this year is our last commercial year. So those roll offs, the big COVID studies roll off, the commercial front end investment rolls off next year or this year's R&D and SG&A, we expect $750 million, next year below $500 million, the year after below $350 million. So what we're able to do, the other side of this agreement with Sanofi in completing our commercialization efforts, is really resize and reshape the company to get to a more lean, agile operating model where we can operate within the parameters of the cash flows coming to us through the Sanofi agreement. We're planning to partner in new cash flows off of flu and CIC. And then you just heard from Bob, the opportunities to partner are Matrix. And we think there are vast opportunities there, both for improving existing vaccines on the market or helping develop new ones.

Vernon Bernardino

Yes, I think this is an important aspect of the investment thesis, because one of the things the company -- in this implementation is to perhaps an evolution to a commercial stage company, at some point, you want the company to be profitable, right? You can't just be spending on R&D all the time, and it's a biotech company, so you're going to plow profits into the pipeline. So there's always going to be some spend. But on the return of that investment, I think, company starts to become really attractive. And I think the homework starts now if it already hasn't been done that if the story starts to become operational breakeven that for those investors who focused on the cash flow aspect of the story, it is probably a good time to do so, because I think and my model only actually has the company capturing 10% of the COVID market, I think it's slightly higher because I think the combination vaccine -- slightly higher for the combination vaccine, because the combination vaccine, I think, will be superior to the competition that the company doesn't really necessarily need to cut that more price that high, capture that much more market share to get to what I believe is currently, right now, an attractive valuation and a price target horizon for those who don't necessarily want to hold the stock long term, which I do recommend. Real quick since we only have about a minute left in time, could you talk a little bit your cash position and perhaps how you might deploy those limited resources into clinical stage activities?

Jim Kelly

Yes, certainly. And important to emphasize, hey, it's our intent to be a profitable company. Like there should be no question about it. I'm not guiding just yet. On hey, you're saying, hey, what quarter? Hey, not guiding just yet. Hey, we're going to -- that's our goal. Our goal and our intent is to be a profitable company where we've been able to do those types of licensing arrangements that bring cash flows into the company that fully support our development efforts. And those efforts we can't wait to unveil as a part of our R&D Day later this year. Important activities that are ongoing include flu CIC that we'll read out by midyear. We've also said that we've initiated IND enabling work around both our RSV and H5N1 programs. You know those are also seeking to become partner ready. And then as we unveil these new pipeline prioritization projects that's where the funding's going to go. So much more on that front as we move forward in the coming months. Can't wait to share more.

Vernon Bernardino

So let's take a little liberty of just one more minute. Can you tell us a little bit about the steps you took and the status of the current launch for Nuvaxovid?

Jim Kelly

By the way, thank you for getting there. Just how quickly we move on to the next one. Hey, the authorization, the EUA that we received from the United States on August 30th, we couldn't be more pleased. They were -- have been such great partners with us. We did so in the summer. We're four or five weeks ahead of where we were last year. We're right here at the beginning of the season in the US, shipped to retail pharmacy late last week, expecting the ability of shots and arms this week, pre-filled syringe, really good contracting work, a lot of credit to our team, retail contracting this year to get us in pharmacies and availability across the country. So we're there. We're there now.

Vernon Bernardino

Terrific. On a personal note, I got my COVID vaccine one week before theirs was available last year. This time, it's going be on time not only because it's earlier but obviously the commercialization -- the authorization is also earlier. So I want to thank Jim Kelly, Dr. Robert Walker for joining us today for presentation on the Novavax. Hopefully, you got a taste and a bit of insight into what attractive investment opportunity this company is. And that if you haven't taken a look before or have perhaps looked in the past but decided to not take a position at that time, I think now is a time. The company is evolving in a positive direction and hopefully you got that insight from them. Thank you.

Jim Kelly

And thanks again, Vernon. Really enjoyed being here. And thank you all.

[Monksdream]

NVAX under $15

[mick]

NVAX
Novavax Inc
11.60
-0.35 (-2.93%)
Volume: 2,767,404
Day Range: 11.43 - 12.12
Last Trade Time: 7:55:52 PM EDT

[JoeForkeyBolo]

I'm surprised. I read about it on Stocktwits and verified for myself on X that the Japan post is gone. It might have been announced prematurely and Takeda wanted it removed. I've seen this happen a couple of times with other companies. We may learn more about this during the conferences Monday and Tuesday where Novavax is presenting. I feel confident this question will be raised. I'll be tuning in to both.

https://ir.novavax.com/press-releases/2024-09-04-Novavax-to-Participate-in-Upcoming-September-Conferences

[justin77]

They deleted the post about Japan approval on both X and LinkedIn! What is your thought about that?

[JoeForkeyBolo]

Japan Approves Novavax Protein-based COVID-19 Vaccine

https://www.precisionvaccinations.com/2024/09/06/japan-approves-protein-based-covid-19-vaccine

Precision Vaccinations News
September 6, 2024

Novavax Inc. announced on X today that its updated 2024-2025 formula COVID-19 vaccine (NVX-CoV2705) has received Marketing Approval from Japan’s Ministry of Health, Labour and Welfare.

As of September 6, 2024, Novavax's vaccine is the only non-mRNA, protein-based COVID-19 vaccine available in the U.S. following the Food and Drug Administration (FDA) granting emergency use authorization.

John C. Jacobs, President, and Chief Executive Officer, Novavax, commented in a recent press release, "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."

Since August 2020, Novavax and Takeda Pharmaceutical Company Limited have partnered to develop, manufacture, and commercialize Novavax’s COVID-19 vaccines.

Before visiting Japan, the U.S. CDC recommends travelers speak with a healthcare provider one month before departure about their vaccination options.

[JoeForkeyBolo]

NEWS: Novavax to Participate in Upcoming September Conferences

https://ir.novavax.com/press-releases/2024-09-04-Novavax-to-Participate-in-Upcoming-September-Conferences

[JoeForkeyBolo]

Novavax appeared on the pitchers mound at Friday's Braves game. I wonder how many in the crowd may have looked up "Novavax" on their smartphone during the game and learned about the FDA approval of their non-mRNA Covid vaccine announced on Friday. Or perhaps looked at share price and took an interest to research the company over the weekend for a possible investment. Advertising dollars well spent, IMO.

[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. 😎