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Msg  176180 of 189356  at  4/24/2022 11:46:44 AM  by

castletower


Novavax Information Newsletter


 

NOVAVAX INFORMATION NEWSLETTER


Below are the most recent items we think are worth sharing with you. It took us far longer than normal to do this newsletter because we wanted to give a deep dive on the trial results that goes beyond the vague, superficial news coverage.

1) 3 reasons why Novavax hit a home run with positive results for its Covid/Flu combination vaccine; Phase 2 trials to begin later this year.


RESULTS:


On the two main criteria we described as being key to the trial results, Novavax hit it out of the park. On top of that, they also nailed it on a criteria we didn't expect. Here's the scorecard:


1) SIDE EFFECTS: you'd think that combining Nanoflu (with 4 different flu strains) and the Covid vaccine would result in at least somewhat higher side effects than just Nanoflu alone or the Covid shot alone. And a decent likelihood of much higher side effects and some likelihood of far higher side effects. But Novavax managed to have the same levels of side effects as either of the vaccines on their own. 


Fluzone has the second best immunogenicity after Nanoflu, which is stronger than Fluzone by between 30% and 70% depending on which flu strain is studied. What would you prefer: a) get an RNA Covid shot one week with high side effects. Then return a week later and get a Fluzone shot with some amount of side effects? or b) get protection against both with one shot with far less side effects than RNA?


Score: A+

2) IMMUNE RESPONSES. For fighting both Covid and flu, the immune responses generated were on par with the vaccines on their own. If the immune responses were somewhat lower, the program likely could have continued because Nanoflu is already far ahead of the second best vaccine, and Novavax's Covid vaccine is somewhat stronger than Pfizer and much stronger than J & J and AstraZeneca. But there was a risk that the immune responses from the combo shot could have been much lower or even far lower, both of which would have probably ended the program. However, 
the immune results were not far lower, much lower or even somewhat lower. They were the same. 


Score: A+

3) MAJOR REDUCTIONS IN ANTIGEN: The results showed it could use as much as 50% less antigen than it did in both doses separately. It also would use 50µg of Matrix M adjuvant total, instead of a total of 125µg if there were two separate shots (50 for the Covid vaccine and 75 for Nanoflu). This means: a) the vaccine can reach more people. b) far higher profit margins. and c) enough extra space available to add an RSV antigen and probably 2 to 3 Covid strains for a total of 3 to 4 Covid strains.

On the last point, even if no reduction in antigen had been achieved, many experts thought Novavax would probably be able to also fit an RSV antigen into the combo vaccine. That would make it protect against the 3 biggest respiratory illnesses in the world. The Covid vaccine has 5µg of antigen, and Nanoflu has 240 µg of antigen (60µg for each strain). If the combo vaccine uses only 120µg of flu antigen, that should free up 120µg of space for 2 or 3 more Covid strains plus the RSV antigen. It should be able to easily do the RSV antigen plus a second Covid strain. 

The RNA vaccines can't get anywhere close to that. They mostly likely can't even get 4 flu stains in one shot. Trying to add even one Covid strain would be pretty much impossible. By contrast, Novavax should be able to easily do 4 flu strains, 2 to 3 Covid stains and RSV in one shot.


Score: A+

Additional bonus: Novavax said that multiple sets of dose sizes and adjuvant sizes were successful. If only 1 had been successful, that's not as promising and there's less wiggle room. Multiple successful options is great.


It's become very clear that Covid vaccines are not going to last more than about 4 to 7 months, kind of similar to flu vaccines. Moderna's bivalent Covid vaccine (with antigen for both Omicron and the original strain) only makes enough antibodies to add about 1 month to its durability. That means people need to get boosted between August and December, and by the following fall, immunity will have dramatically waned. Most governments, healthcare systems and insurance companies will put major efforts into fall vaccination drives in order to greatly reduce healthcare costs, save lives, prevent hospitals from being overwhelmed and reduce economic losses.


Many people are misinterpreting that governments and health experts aren't doing very much to get people to receive additional shots now. Governments and experts know that: 1) most people around the world completed their primary series between April and November of 2021, and half of people don't want to get a shot more than once a year. So a lot of people are not even at the 12 month mark. 2) they also know that many people at the moment have Covid fatigue and the timing isn't ideal to push another shot so soon. and 3) If most people will only get 1 shot per year, it's best for it to be between September and November so immunity is high during the Covid season. The last 2 years every country in the world was hammered between December and January.


Most governments, most experts, most doctors and most insurers know what's at stake this coming fall and winter. They will do a promotional blitz for Covid shots, and the media will be on board. Many media outlets and health experts will point out that there's a high efficacy alternative for people who are hesitant about RNA.
PRESS RELEASE: Here is an excerpt from Novavax's press release:


The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic. ...


The safety and tolerability profile of the combination vaccine was consistent with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza vaccine reference formulations in the trial. The combination vaccine was found to be generally well tolerated. Serious adverse were rare and none were assessed as being related to the vaccine.


Here's the link to the press release:

https://ir.novavax.com/2022-04-20-Initial-Results-from-Novavax-COVID-19-Influenza-Vaccine-Trial-are-First-to-Show-Feasibility-of-Combination-Vaccine


ARTICLE: Here are excerpts from an article about the combination vaccine:


Novavax Inc.’s experimental combination vaccine for Covid-19 and the seasonal flu just got some good news. ....

But these results thus far allow the company to start a phase 2 trial by the end of the year, said Dr. Filip Dubovsky, chief medical officer for Novavax (NASDAQ: NVAX). In doing so, he said, the company will also evaluate the best dosage for a planned final phase of testing, among a larger group of patients, to determine if it indeed protects against both Covid and the flu.


The latest trial also found similar outcomes for the combination candidate’s safety and tolerability, when compared with the stand-alone vaccines. Serious side effects were rare and unrelated to the vaccine, the company said. .... Novavax had started enrolling patients in this study in September, about six months after first considering the concept.


The company aims to eventually earn FDA approval for the combination vaccine, which Novavax President and CEO Stanley Erck has called “a key component” of its pipeline. ....


TIMING OF PHASE 2 START: Though Novavax said the trial would start "by" the end of the year, many investors in online discussion forums thought it meant "at" the end of the year, and expressed disappointment it wasn't sooner. However, we recommend considering the following points:

* When Novavax did one of the Nanoflu trials, one of the flu strains changed at the last minute, and it took about 1 1/2 months longer than planned for them to obtain the supplies needed for that trial. They were hammered by news outlets and many investors, even though the change in strain was not their fault. In the last year, they've also been viciously attacked every time an estimated frame didn't pan out. So it's likely they've decided to be 
conservative with any timelines. 


* Last year, Novavax said on a Friday that they'd release some results sometime in the next week and released them on Monday, about 1 business day into the 5 business days. Also, on one of their Nanoflu trials, they said they expected results by the end of Q1, and they released them on January 3rd. So while more than half of the time the action occurs near the end of the period, and much of the time it occurs after the end of the period, some of the time it's very, very early in the time range.


* They progressed the Nanoflu trials very rapidly, completing 3 of them in only 3 years. For the Covid vaccine, they started their phase 1, phase 2, and UK phase 3 trials very rapidly. They also first stated an intention to do a combination vaccine in March, 2021 and 5 1/2 months later they started the first trial. 5 1/2 months from the date of these results is early October. Also, the majority of the design of phase 2 is already done. So it could possibly start in August or September. 


Whether they start the phase 2 in September or December, they're far ahead of everyone else and they are the only company with a clear path to success, given the RNA vaccines won't be able to pull off a combo shot, and viral vectors can't do it. Sanofi is the only other company with a shot, and they have been blowing off doing a combination vaccine. Plus, they don't even have an approved Covid vaccine yet. Also, their flu shot is weaker, and their Covid vaccine would probably also be weaker, if it even gets authorized at all.

In a future newsletter, we'll examine the size of the combination vaccine market. 


2) After meeting with the Novavax CFO, Jefferies analysts increase their estimated Q1 earnings to $3.67 per share, 2022 earnings to $37.92 per share and price target to $198


Here is a relevant clip with the latest price target and Q1 estimate for Novavax:


Stock analysts at Jefferies Financial Group raised their Q1 2022 EPS estimates for shares of Novavax in a report released on Tuesday, April 19th. Jefferies Financial Group analyst Roger Song now anticipates that the biopharmaceutical company will earn $3.67 per share for the quarter, up from their prior forecast of $3.55. Jefferies Financial Group has a “Buy” rating and a $198.00 price target on the stock. .... According to MarketBeat.com, the stock currently has an average rating of “Buy” and an average price target of $204.86. 



After meeting with the Novavax CFO, Jefferies also gave the following quarterly forecasts for this year,  and annual forecasts for the next four years: 


Stock analysts at Jefferies Financial Group boosted their Q2 2022 earnings per share estimates for Novavax in a note issued to investors on Tuesday, April 19th. Jefferies Financial Group analyst R. Song now expects that the biopharmaceutical company will earn $6.94 per share for the quarter, up from their previous estimate of $4.34. Jefferies Financial Group has a “Buy” rating and a $198.00 price objective on the stock. Jefferies Financial Group also issued estimates for Novavax’s Q3 2022 earnings at $10.86 EPS, Q4 2022 earnings at $16.14 EPS, FY2022 earnings at $37.92 EPS, FY2023 earnings at $13.95 EPS, FY2024 earnings at $9.57 EPS, FY2025 earnings at $11.36 EPS and FY2026 earnings at $13.10 EPS.


The average EPS from 2022 to 2026 is $17.18 per share. At a PE ratio of 10, the valuation is $171.8 per share. At a PE of 15, it's $257.7. Note that the Jefferies price target of $198 and the MarketBeat consensus target of $204.86 are both between those two. Here is the link: 

https://www.defenseworld.net/2022/04/21/novavax-inc-nasdaqnvax-forecasted-to-post-q2-2022-earnings-of-6-94-per-share.html

3) FDA clarifies no data is missing from the Novavax EUA filing. Novavax says it expects FDA expert panel to be scheduled "very soon."


DETAILS: 


• In a CNBC story at around the same time as the combination trial results, an FDA official said the review of the Novavax vaccine was complex, and implied that needed data was missing. This blunted the positive news from the trial results, as the share price actually went down instead of up. Later the FDA made a statement to Yahoo Finance clarifying that no data was missing. Also in the Yahoo Finance article, both the FDA and Novavax conveyed that nothing was wrong, and that they are only engaged in the normal back and forth of questions during a review period. 

However, the CNBC story got about 10 times as much coverage, partly because CNBC's audience is far bigger than Yahoo's, and partly because other news outlets picked up the CNBC story. The CNBC story scared many investors. It should be noted that every other major drug agency in the world was able to pretty easily handle the Novavax filing, and many far smaller drug agencies were able to handle the filing and review it quickly. This includes Australia, whose population of 25 million people is only 8% the size of the US; the UAE, which is 3% of the size of the US; and Switzerland, which is 2.5% of the size of the US. So the attempt by the FDA official to make an excuse for the FDA's tardiness was quite inaccurate.

Here is a clip from an article that includes the quote from the FDA official:


At a meeting convened by the Centers for Disease Control and Prevention (CDC), Dr. Doran Fink, a deputy director of FDA’s Center for Biologics Evaluation and Research (CBER), acknowledged that some are anxiously waiting for the entry of an alternative to current vaccine options.


Novavax (NVAX) COVID-19 shot, identified as NVX-CoV2373, is a protein-based vaccine authorized in multiple countries and regions, including Europe. However, the Maryland-based biotech has yet to receive the FDA nod for the vaccine even months after the regulatory submission.


“This is an incredibly complex review process that involves review of not just clinical data but also manufacturing data that will be needed to make a determination about emergency use authorization,” Dr. Fink said, according to CNBC’s Meg Terrel.


“And once we have all the data we need to complete our review, again, we will work diligently to present those data to our advisory committee and in a timely manner in order to make a decision,” Dr. Fink added.


Here is the link to the full article:
https://seekingalpha.com/news/3824926-nvax-stock-in-focus-as-fda-highlights-challenges-for-review-of-covid-19-shot


• Here are excerpts from the Yahoo Finance article:


Dr. Gregory Glenn, president of research and development, told attendees at the World Vaccine Congress the company was optimistic about its COVID-19 emergency use authorization (EUA).


In a statement later in the day, the company said, "We continue to have a productive dialogue with the FDA as they review data and we answer inquiries related to clinical and manufacturing data as expected. We look forward to scheduling our VRBPAC [Vaccines and Related Biological Products Advisory Committee] meeting in the near future as indicated by the FDA."


At an advisory committee for the U.S. Centers for Disease Control and Prevention (CDC) Wednesday, a U.S. Food and Drug Administration official indicated that the FDA was still awaiting manufacturing data from Novavax.


But an FDA spokesperson later said it was nothing more than the usual back-and-forth as part of the regulatory process.


"While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the EUA request as expeditiously as possible using its thorough and science-based approach. The agency plans to schedule a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the EUA request with the FDA’s panel of outside scientific and medical experts," according to the spokesperson. ....


Neither side indicated that there was any delay in the process. 


View the article:


A local business journal also reported the following:


The company said it couldn't offer a specific timeline for the FDA's decision on its Covid vaccine under review for emergency use. It also plans to seek full approval for that vaccine in the U.S. in the second half of 2022, Erck said on a company earnings call earlier this year.

“We interact with [the FDA] frequently. It’s a friendly interaction and they’re just reviewing the file,” Dubovsky said Wednesday.

4) Novavax announces new vaccine booster study in adolescents in Phase 3 Prevent trial


Here is an excerpt from Novavax's press release on the announcement of a new vaccine booster study:


The study will evaluate the safety and immunogenicity of a third dose of NVX-CoV2373 among trial participants aged 12 through 17.


"We see the ongoing need for alternative vaccine options because we are continuing to monitor spikes in COVID-19," said Gregory M. Glenn, M.D., President, Research and Development, Novavax. "The expansion of our PREVENT-19 booster trial into the pediatric population reinforces our commitment to seek to make our vaccine available to a broader population."


All PREVENT-19 trial participants aged 12 through 17 are now eligible to receive a third booster dose of NVX-CoV2373. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant spike protein plus 50 micrograms of Matrix-M™ adjuvant) and may be administered at least five months after receipt of active vaccine. Post-booster objectives include the assessment of the humoral immune response 28 days after the administration of the booster dose, as well as describing COVID-19 disease. Initial results are expected during the second half of 2022.


Here is the link to the press release:

https://ir.novavax.com/2022-04-22-Novavax-Announces-Initiation-of-COVID-19-Vaccine-Booster-Study-in-Adolescents-in-Phase-3-PREVENT-19-Trial


5) US Justice appeals ending of mask mandate on public transportation and airplanes


The US Justice Department has appealed the ending of a mask mandate on public transportation and airplanes as there is no end to Covid in sight. Despite wishful thinking from much of the public, the pandemic is not over and the virus continues to mutate. There have been at least 10 new mutations, one of which has already spread rapidly. Here is an excerpt from an article:


The U.S. Justice Department on Wednesday appealed a judge's ruling ending a mask mandate on public transportation and airplanes, a spokesman said, after the Centers for Disease Control and Prevention (CDC) said the measure was still needed.


A U.S. district judge ruled on Monday that the mandates, which apply to planes, trains and other public transportation, were unlawful. The Justice Department said it would appeal the ruling if the CDC determined the 14-month-old mandate was still needed.


Here is the link to the article:

https://www.reuters.com/world/us/cdc-wants-justice-department-appeal-transportation-mask-ruling-2022-04-20/

 

The Novavax Information Newsletter

Please forward this newsletter to other current or potential Novavax investors, and spread the word about it online. To sign up for it, go here: https://novavaxinformation.com.

Disclaimer: The newsletter is not investment advice or recommendations, and nothing in it should be considered such. We are not responsible for nor liable for how you use, or what you do with the content provided in the newsletter. By opening or reading this newsletter, you agree to indemnify all entities and people involved with the newsletter from any liability or damages. This newsletter is not published by, endorsed by or affiliated with Novavax Inc. in any way.

 
 


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