Novavax Inc (NVAX) 銘柄情報

Novavax Announces Grant of Inducement Awards Pursuant to Nasdaq Listing Rule 5635(c)(4)

GAITHERSBURG, Md., Nov. 15, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that the Company granted a non- qualified stock option and restricted stock units to Ruxandra Draghia-Akli, MD, PhD, its newly appointed Executive Vice President and Head of Research & Development, as a material inducement for her entry into employment with Novavax, effective as of November 11, 2024 (the "grant date"). These awards were approved by the Compensation Committee of Novavax and were granted in accordance with Nasdaq Listing Rule 5635(c)(4) and pursuant to the Novavax, Inc. 2023 Inducement Plan.

The non-qualified stock option is an option to purchase 64,150 shares of Novavax's common stock with a per share exercise price of $9.01, the closing price of Novavax's common stock on the Nasdaq Global Select Market on the grant date. The non- qualified stock option has a ten-year term and will vest as to one-quarter of the underlying shares on the first anniversary of the grant date, and as to the remaining shares in equal monthly installments for 36 months thereafter, in each case generally subject to Dr. Draghia-Akli's continued employment with Novavax through the applicable vesting date. The restricted stock units are with respect to 42,770 shares of Novavax's common stock and will vest as to one-third of the restricted stock units on each of the first three anniversaries of the grant date, in each case generally subject to Dr. Draghia-Akli 's continued employment with Novavax through the applicable vesting date. The non-qualified stock option and restricted stock units are subject to the terms and conditions of the Novavax, Inc. 2023 Inducement Plan.

https://ir.novavax.com/press-releases/2024-11-15-Novavax-Announces-Grant-of-Inducement-Awards-Pursuant-to-Nasdaq-Listing-Rule-5635-c-4

Novavax Reports Third Quarter 2024 Financial Results and Operational Highlights

https://ir.novavax.com/press-releases/2024-11-12-Novavax-Reports-Third-Quarter-2024-Financial-Results-and-Operational-Highlights

U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.

"We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package," said Robert Walker, MD, Chief Medical Officer, Novavax. "The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible."

The clinical hold announced on October 16, 2024, resulted from a spontaneous report of a serious adverse event in a participant who received investigational CIC vaccine in a Phase 2 trial that completed in 2023. The FDA had requested additional information on this event, initially reported as motor neuropathy. The additional information included a change in the event term to amytrophic lateral sclerosis, a condition that is not known to be immune-mediated or associated with vaccination, which in this event was assessed as not related to vaccination.

https://ir.novavax.com/press-releases/2024-11-11-U-S-FDA-Removes-Clinical-Hold-on-Novavaxs-COVID-19-Influenza-Combination-and-Stand-alone-Influenza-Phase-3-Trial

I read on another board that both Pfizer and Moderna reported better than expected Q3 Covid vaccine sales, so with the increased awareness of Novavax vaccine option compared to previous years, hopefully we get better than expected results as well on next Tuesday's earnings call.

Thanks for your recon. Much appreciated.

Great news! I just left the CVS and spoke to the pharmacist, the box of vaccines for Novavax for the month of October was all used up. They just received another box for the month of November, so I’m assuming each store. is going to get one box a month. Thank you for all the good information you guys post hopefully the next two CVS stores I pick up at will tell me the same thing. your friendly neighborhood mailman

Form 8-K Filing

Item 1.01 Entry into a Material Definitive Agreement.

On November 1, 2024, Novavax, Inc. (the “Company”) and The Secretary of State for Health and Social Care, acting as part of the Crown, through the UK Health Security Agency (the “Authority”), entered into a Termination and Settlement Agreement (the “Settlement Agreement”) and a Letter of Amendment to the Settlement Agreement (the “Settlement Agreement Amendment”), relating to the Amended and Restated SARS-COV-2 Vaccine Supply Agreement effective July 1, 2022 (the “Amended and Restated Supply Agreement”) by and between the Company and the UK Secretary of State for Business, Energy and Industrial Strategy, acting on behalf of the Crown, settling the disputes regarding the Amended and Restated Supply Agreement and releasing both parties of all claims arising out of or connected with the Amended and Restated Supply Agreement.

Under the terms of the Settlement Agreement, the Authority and the Company agreed to terminate the Amended and Restated Supply Agreement and to fully settle the outstanding amount under dispute related to upfront payments previously received by the Company from the Authority under the Amended and Restated Supply Agreement. Pursuant to the Settlement Agreement, the Company agreed to pay a refund of $123.8 million (the “Settlement Payment”) to the Authority in equal quarterly installments of 10.3 million over a three year period, ending on June 30, 2027. The Settlement Payment amount includes a $11.3 million provision for interest over the period and may be avoided if the Company chooses to accelerate payments. Under the terms of the Settlement Agreement Amendment, the Authority and the Company agreed to make the first quarterly installment payment due on November 30, 2024.

The foregoing descriptions of the material terms of the Settlement Agreement and the Settlement Agreement Amendment does not purport to be complete and is qualified in its entirety by reference to the Settlement Agreement, which will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Annual Report on Form 10-K for the year ended J December 31, 2024.

Item 1.02 Termination of a Material Definitive Agreement.

In connection with the parties’ entry into the Settlement Agreement, the Company and the Authority terminated the Amended and Restated Supply Agreement.

The information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference in this Item 1.02.

Form 8-K

Novavax to Host Conference Call to Discuss Third Quarter 2024 Financial Results and Operational Highlights on November 12, 2024

GAITHERSBURG, Md., Nov. 4, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced it will report its third quarter 2024 financial results and operational highlights at 8:30 a.m. Eastern Time (ET) on Tuesday, November 12, 2024.

Details of the event and replay are available at the link below:

https://ir.novavax.com/press-releases/2024-11-04-Novavax-to-Host-Conference-Call-to-Discuss-Third-Quarter-2024-Financial-Results-and-Operational-Highlights-on-November-12,-2024

"Vanguard Group Inc ownership in NVAX / Novavax, Inc.
2024-11-04 - Vanguard Group Inc has filed an SC 13G/A form with the Securities and Exchange Commission (SEC) disclosing ownership of 15,430,034 shares of Novavax, Inc. (US:NVAX). This represents 9.63 percent ownership of the company. In their previous filing dated 2024-02-13 , Vanguard Group Inc had reported owning 14,560,054 shares, indicating an increase of 5.98 percent."

https://fintel.io/so/us/nvax/vanguard-group

https://www.sec.gov/Archives/edgar/data/102909/000093247124000542/UnitedStates_13G__NovavaxInc.txt

NVAX, 10Q 11/7

NEWS: Åsa Manelius Named Managing Director of Novavax AB Site

November 4, 2024

Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Åsa Manelius, will join the Company in February 2025 as Managing Director of the Novavax AB site in Uppsala, Sweden, the primary manufacturing site for Matrix-M.

Ms. Manelius brings more than 25 years of experience leading global operations and most recently worked at AstraZeneca in Södertälje, leading the global supply chain for its Respiratory & Immunology therapy area. Prior to this role, she served as the General Manager of AstraZeneca’s Sweden Biologic Center, a global commercial and strategic launch site for biological medicines.

“Åsa brings deep global operations knowledge to Novavax during a critical time of transition for the Company,” said Rick Crowley, Chief Operations Officer, Novavax. “As we focus on driving value via our proven technology platform through partnerships and R&D, Åsa and our AB site will be critical to ensuring robust supply of our best-in-class Matrix-M™ adjuvant for both our pipeline and potential partners.”

“I’m excited to join Novavax and look forward to bringing my deep expertise in development, CMC activities and manufacturing operations to its adjuvant business,” said Ms. Manelius. “There is tremendous potential in Novavax’s Matrix-M™ technology, and I look forward to working with the team to create a true center of excellence in Uppsala.”

Ms. Manelius previously served as Managing Director at Biora AB and in executive leadership roles at Pfizer Health AB. She received an MSc/Chemical Engineering and a PhD in Biotechnology/Biochemical Engineering from Lund University.

https://ir.novavax.com/press-releases/Asa-Manelius-Named-Managing-Director-of-Novavax-AB-Site

Theory vs reality is very different for this stock

https://time.com/7094916/university-of-oxford-and-the-serum-institute-of-india-r21-matrix-m/

Great spotlight for Novavax....should move the SP in theory.

Yes, I was told the same thing end of October is expiration date and I was also told that the CVS computer pushes out Pfizer because they have more doses, So they try and push out whatever product they have more of, so it’s rigged against Novavax , Because they have a small amount of products on hand

FWIW, got our shots at Rite Aid a week ago. Requested to see the prefilled syringe, noted expiry date was October. Pharmacist said they will place another order.

Are there any other mailmen across the country, who could do the same? that could help a lot with figuring out, how many doses have been given out? Thank you

Hi, I am a mailman, we pick up packages at CVS every day at 4 o’clock. I have been doing that for the last five years and I have become friendly with the pharmacist. I asked them how many doses they have left each store received one box of 10 doses out of 30 doses at three stores 21 were administered. I know it’s only three stores, but I thought maybe this might help people out. this was as of three weeks ago. I am going to ask them again tomorrow and Saturday.

NVAX under $10

Today I completed a full conversion of Novavax shares in my regular IRA to my Roth IRA. The share price hasn't been this low since before the Sanofi deal. It may go lower but every day waiting for a lower conversion price is another day news could break sending share price higher. My state doesn't tax IRA withdrawals or conversions, so I only have the federal tax bill to deal with. If Novavax succeeds this will be looked upon as a very smart move. If not, life goes on.

Looking forward to Q3 call and update on FDA hold.

JUST CHARTING

Hi, just wondering what you are trying to convey in the chart....something of significance? Thanks.

Discussion on FDA hold from another board.

NEWS: Update on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

October 16, 2024

GAITHERSBURG, Md., Oct. 16, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The clinical hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside of the U.S. who received the vaccine in January 2023. The trial completed in July 2023 and the participant reported the SAE in September 2024.

"We are working closely with the FDA to provide the necessary information that will allow them to better understand this observation and resolve the clinical hold," said Robert Walker, MD, Chief Medical Officer, Novavax. "It is important to note that safety is our top priority, and while we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA. Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible."

Data from Novavax's previous COVID-19 and influenza trials have shown no signals for motor neuropathy. Investigators have been informed of this action. The COVID-19 IND for Novavax's COVID-19 vaccine is not impacted by the clinical hold.

https://ir.novavax.com/press-releases/2024-10-16-Update-on-Novavaxs-COVID-19-Influenza-Combination-and-Stand-alone-Influenza-Phase-3-Trial

Also, Form 8-K filed with SEC.

Mater Research initiates combined Covid-flu vaccine trial

October 14, 2024

Mater Research in Brisbane, Australia, has commenced a clinical trial for a new combined Covid-19 and flu vaccine from Novavax aimed at providing protection for individuals who are unable to receive mRNA vaccines.

This non-mRNA vaccine is protein-based and includes a segment of the coronavirus spike protein.

It is designed to trigger an immune response by introducing a harmless piece of the coronavirus spike protein to the immune system.

As the immune cells recognise the spike protein as a foreign invader, they start to build a defence against it.

Eligible volunteers will include healthy individuals over the age of 65 years who have not received an influenza vaccine in the past two months.

The trial is set to commence on 4 November and will span a three-week period.

https://www.clinicaltrialsarena.com/news/mater-research-initiates-combined-covid-flu-vaccine-trial/

Shares available to short dropped by 500K shares this morning, indicating a possible short attack at the open. If you're looking to buy NVAX shares at a lower price today you'll likely get your chance.

Source: fintel.io/ss/us/nvax

Novavax Poised for U.S. Market Capture and Cost Efficiency Gains: A Resounding Buy Rating

https://markets.businessinsider.com/news/stocks/novavax-poised-for-u-s-market-capture-and-cost-efficiency-gains-a-resounding-buy-rating-1033671123

B.Riley Financial analyst Mayank Mamtani reiterated a Buy rating on Novavax (NVAX – Research Report) today and set a price target of $23.00.

Mayank Mamtani has given his Buy rating due to a combination of factors surrounding Novavax’s strategic positioning and operational progress. He highlights the company’s readiness to capture the U.S. commercial COVID market for the upcoming Fall ’24 season, strengthened by finalized retail pharmacy contracts covering over 17,000 locations—a significant increase from the prior fiscal year. Additionally, Mamtani notes Novavax’s effective recalibration of its cost structure, which has led to a substantial reduction in operating expenses, and anticipates further cost savings in the future. These improvements in operational efficiency, coupled with the company’s plan to strategically exit most ex-U.S. territories, reinforce the analyst’s positive outlook on Novavax’s stock.

Furthermore, the potential for regulatory and commercial success of Novavax’s late-stage pipeline, particularly the COVID-influenza combination vaccine and stand-alone flu programs, underpins the Buy rating. Mamtani emphasizes the company’s alignment with FDA plans for a single Phase III immunogenicity study, which could expedite the approval process. He also points out the anticipated milestone payments from the partnership with Sanofi, which are expected to bolster Novavax’s financial position. Despite a downward revised FY24 guidance, largely due to the exclusion of future Advance Purchase Agreements (APAs), Mamtani’s analysis suggests confidence in Novavax’s ability to navigate the market and capitalize on its U.S. commercial strategy and pipeline advancements, justifying a Buy rating with a price target of $23.

Novavax Covid-19 vaccine now available in Poland

https://leki-pl.translate.goog/poradnik/czy-w-polsce-dostepna-jest-nowa-szczepionka-przeciwko-covid-19-news/?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=wapp

Thoughts from another board on short positions...

Thanks. The groups and individuals behind the shorting of this stock, and their reasons for shorting it, are the subject of many a twitter theory. Holding on the fundamentals of the superiority of the covid vaccine, the potential of the platform, and the potential of Matrix-M to other partners.

Shorts borrowed 1.1M shares and attacked stock at the open. Doesn't make sense. I expect price to recover over the day.



https://fintel.io/ss/us/nvax

Please tell me how the SP drops on such news....? Sigh. EU approval roughly 3 weeks earlier than last year.

NEWS: Novavax's Updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine Receives Authorization in the EU

https://ir.novavax.com/press-releases/2024-10-09-Novavaxs-Updated-2024-2025-Nuvaxovid-TM-COVID-19-Vaccine-Receives-Authorization-in-the-EU

Continuing to trade on dips created by the short-sellers. As of today's close, have added a total of 2,780 free shares and lowered cost basis from initial $5.65 to current $4.90/share. I plan to continue this practice until short-sellers move on. Hopefully that is sooner rather than later. Great news coming this quarter on multiple fronts, IMO.

Analysts upgrade and downgrade it all the time. So I believe that is something else brewing for this 20% raise yesterday. I cannot comprehend it just to be because one analyst said it's worth $31 .  100% confident about it

Novavax Stock Gains Retail Spotlight After Jefferies’ Bullish Call, Firm’s Subsequent Clarification: Retail Turns Exuberant

Bhavik Nair·Stocktwits
Published Oct 3, 2024

The brokerage reportedly indicated that it caught up with Novavax management and believes that for the near term, the firm is in "a good position" to meet its 2024 revenue guidance.

Novavax Inc (NVAX) stock became the second most trending ticker on Stocktwits on Thursday morning after Jefferies gave a ‘Buy’ rating to the stock with a price target of $31. The target represents a potential upside of over 100% from the stock’s current level.

The brokerage reportedly indicated that it caught up with Novavax management and believes that for the near term, the firm is in "a good position" to meet its 2024 revenue guidance, driven by the U.S. market. Jefferies also reportedly said that according to the company, a majority of the 24/25 COVID-19 season sales will be in Q4.

“For the long term, the company is transitioning to an R&D model, with Phase 3 flu +/- CV19 as the lead that could trigger a major partnership in 2025 and new non-seasonal vaccines based on unique adjuvant technology as an earlier pipeline that would drive significant future growth,” Jefferies reportedly said.

Following the update, shares of Novavax had closed over 19% higher on Wednesday. However, Novavax came out with a clarification in an SEC filing.

The firm stated that it is aware of an analyst report published on Oct. 1, 2024, which referred to discussions with Novavax’s management regarding the anticipated U.S. market for COVID-19 vaccination for the 2024-2025 vaccination season.

“Novavax would like to clarify that while it has anticipated the COVID-19 vaccination market in the U.S. will be similar to last year, it has neither updated nor reaffirmed its full year 2024 financial guidance issued on August 8, 2024,” it clarified.

Shares of Novavax were trading over 5% lower in Thursday’s pre-market session. However, retail investors on Stocktwits turned ‘extremely bullish’ (80/100) from ‘bearish’ a day ago.

Notably, Novavax shares are up over 191% since the beginning of the year, significantly outperforming the benchmark indices. Stocktwits users with a ‘bullish’ outlook believe the shares are likely to rally in the coming times.
https://stocktwits.com/news-articles/markets/equity/novavax-stock-in-focus-after-bullish-takes-from-jefferies/cJccSbkR3r

Novavax Form 8-K filed 10/3/24

Form 8-K
Novavax, Inc. (“Novavax”) is aware of an analyst report published on October 1, 2024, which referred to discussions with Novavax’s management regarding, among other things, the anticipated U.S. market for COVID-19 vaccination for the 2024-2025 vaccination season. Novavax would like to clarify that while it has anticipated the COVID-19 vaccination market in the U.S. will be similar to last year, it has neither updated nor reaffirmed its full year 2024 financial guidance issued on August 8, 2024.

Yes. And with this paper we have a plausible mechanism why this may happen with mRNA vaccines. We would need the same data from Novavax to confirm that it does happen with it and that it creates the various memory cells in bone marrow that are typical of other protein-based vaccines. But it likely does this, as its protection is longer lasting.

I believe this issue is specific to mRNA Covid vaccines. It has been shown in testing that immunity wanes significantly after as little as 3 months, while the Novavac Covid vaccine immunity remains high for 8 months or more after vaccination.

Jeffries Reiterates Buy Rating on Novavax, Target Price $31.00

Check out the new Nature paper that shows mRNA vaccines don't produce immune memory cells in bone marrow. Didn't know this until now. Another knock against mRNA it would seem...and this appears significant. Unknown if same holds for Novavax...but unlikely given its platform type.

"SARS-CoV-2-specific plasma cells are not durably established in the bone marrow long-lived compartment after mRNA vaccination."

https://www.nature.com/articles/s41591-024-03278-y

The NIH Clinical Trials database currently shows the following trials where Novavax Matrix-M adjuvant is used. Link provided to this search in case anyone wants to dig deeper in the trials listed.

28 trials – not yet recruiting
69 trials – recruiting
25 trials – active, not recruiting

https://clinicaltrials.gov/search?term=%22Matrix-M%22&limit=100&aggFilters=status:act%20rec%20not

I'm very excited to be a Novavax shareholder.

COVID IS OVER. Stock with the scare tactics

I've been continuing to trade on dips created by the short-sellers. As of this morning, have added a total of 1,883 free shares and lowered cost basis from $5.65 to $5.12/share. My goal is to roll profits back into repurchase of more shares, which I'm holding until the eventual buyout that I expect within 1 - 3 years.

This trading opportunity won't last much longer, IMO. Shorts are going to get burned badly on news of another partner, public announcement of Sanofi's plans for Matrix-M adjuvant, EMA approval of the Covid vaccine, and update on new Novavax pipeline.

While frustrating for now, the short-sellers will eventually move on to easier targets than NVAX.

Novavax's new COVID-19 vaccine gets emergency use approval in South Korea

https://en.topdaily.kr/articles/2817

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

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/

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.

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

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.

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