GBA's "2021 Stock Phantasma"

janes · Jun 14, 2021

looks like novavax NVAX just announced their us/mexico study results and all seems well. up 12% pre-market.

janes · Jun 14, 2021

stonedinvestor said:
Paid to play? No! $90K for that article.... I don't think Yahoo would do that but you never know.

The splitting of divisions is what's interesting in this name and the emphasis on green ammonia.

the volume! I wonder if that is why-- not the yahoo but wherever elee they may have been promoted?
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yah i think they're pumping the stock right now, so it might keep going up for a bit. i don't know if yahoo got paid or just took the free article, but it's the exact same thing that was a paid article on that other website

stonedinvestor · Jun 14, 2021

stonedinvestor said:
Interesting- The Gov has begun backtracking on the booster shot because so many are apprehensive about getting the first shot and many like me do not plan to get yearly " boosts "
Yet as this thing simmers in Africa no doubt a variant will come out eventually that will need to be addressed. Especially of it's fatal.

Jun. 07, 2021 8:21 AM ETNovavax, Inc. (NVAX)
Summary

Stronger side effects and heart inflammation could potentially hamstring mRNA vaccines.

Novavax has the winning proposition on a direct comparison with BioNTech and Moderna.

Novavax could potentially generate a long-term Covid vaccine income stream on a Gross Profit basis in excess of $10bn per annum.

Novavax's share price is materially undervalued and could literally reprice to multiples of the current share price.

2+2=4?

Two unrelated scientific studies may very well indicate that the only Covid vaccine booster shot on offer over the longer term will be the one produced by Novavax.

The First 2
In a study published in Nature magazine, Danny Altmann, British immunologist, and Professor of Immunology at Imperial College London, observes the following: "Repeated doses of virus-based vaccines such as the Oxford–AstraZeneca one tend to be increasingly less effective because the immune system mounts a response against the adenovirus.RNA vaccines, by contrast, tend to trigger stronger side effects with added doses.” (My emphasis)

We do know that the safety data published by BioNTechon the side effects of their mRNA vaccine supports the observation of Prof. Altmann.

“Systemic events were reported more often by younger vaccine recipients (16 to 55 years of age) than by older vaccine recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1.”

The same result was reportedby Moderna(MRNA).

“The severity of the solicited systemic events increased after the second dose in the mRNA-1273 group, with an increase in proportions of grade 2 events (from 16.5% after the first dose to 38.1% after the second dose) and grade 3 events (from 2.9% to 15.8%).”

TheCDC reports on Pfizer-BioNTech(PFE) (BNTX): “Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first.”

TheCDC reports on Moderna: "Side effects (such as fever, chills, tiredness, and headache) throughout the body were more common after the second dose..."

Thus, there is direct mRNA Covid vaccine safety evidence supporting the observation of Prof Altmann, but it is limited to the two doses used so far. Will this trend actually materialize in the 3rdand 4thdoses going forward? This uneasy question is not fully answered, yet, but it does indicate a very real commercial risk for the mRNA vaccines and the mRNA vaccine platform.

The Second 2
The second 2 is the emergence of a relatively recent safety issue now with a “probable link” to mRNA vaccines.Israel first reported the safety issueof heart inflammation in late April 2021.

It is also under investigation by the USA CDC and on 2 June 2021 Bloomberg reports that theIsrael health officials have found a “probable link”between the Pfizer/BioNTech Covid vaccine and heart inflammation in younger men. Adding to the severity of side effects escalation observation, this link to heart inflammation is observed alsoafter the 2nddose.

Adding 2+2 to get 4, says that not only will side effects increase with increased doses but also that a severe event such asaheart inflammation which is rare after the second dose may become less rare and more prevalent. Do we have proof for such a hypothesis at this stage? No. Is it possible or even likely that the hypothesis may hold when by the time that 3rdand 4thdoses are administered? Yes.

Can or should one ignore this potential existential risk to mRNA vaccine makers when making a commercial decision on buying or holding shares of mRNA vaccine makers? Your call.

The next Covid vaccine battle is Boosters
BioNTech/Pfizer and Moderna in close second place won the race for Covid vaccination. Safety events after vaccine rollout undermined the competitive positions of the adenovirus vaccines of AstraZeneca and J&J, as well as the Russian and Chinesemanufacturers. Safety was already questioned at the time of their initial rollouts but the blood clotting issue, even though rare andruled an acceptable risk, relegated them to use only when there was no other choice.

Would we need a similar ruling in the future on the mRNA Covid vaccines with regards to heart inflammation and the escalation of severity in side effects after every dosage? Perhaps, time will tell.

The two mRNA vaccines are presently dominating expectations of servicing the Covid vaccine booster market. That is not as certain as expected given the risk of escalating severity of side effects and heart inflammation. Relegate the mRNA’s (that includes CureVac) to the same space as the adenovirus vaccines and the only remaining Covid vaccine contender for the winning booster shot is Novavax. Does Novavax really need safety issues with mRNA vaccines to compete in the Covid vaccine booster space? Let’s have a look.

The Novavax Covid Vaccine vs mRNA Covid Vaccines of BioNTech and Moderna
Type of vaccine.

Novavax describes the vaccine as follows:

“NVX-CoV2373is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2... using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike(NYSE:S)protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19."

I found anexcellent article from ScienceMag.orgpublished in November 2020 that provides the best description of the Novavax Covid vaccine, as well as telling the story of Novavax’s rise and fall and rise again. It is a bioengineering process. Scientists piggyback a mimic Covid spike protein production using an insect-infecting baculovirus. The process starts by inserting the gene for the SARS-CoV-2 spike protein into the baculovirus, then infecting fall armyworm moth cells. Mimic Covid spike proteins subsequently form on the moth cell membranes for harvesting and processing into a protein-based Covid vaccine candidate.

The most important points are:

It’s a well-known technology. Manufacturing can be scaled, and boosting is not a problem. “Companies also already know how to manufacture recombinant proteins at scale.‘This is established technology that has been around for decades,’ says Peter Hotez, vaccine scientist at Baylor College of Medicine in Houston, US.”

Can be combined with an annual Flu vaccine and Novavax has already created such a combination vaccine, NanoFlu™/NVX-CoV2373 combination vaccine candidate, for which they have already published very promisingpre-clinical data.

Can rapidly respond to variants and mutations. “While many experts see the nimble mRNA technology that underlies the Pfizer and Moderna vaccines as the way of the future,Novavax executives maintain that it’s relatively simple to modify their vaccineto target different or multiple strains of the coronavirus.”

Can beformulated as a multivalent(multivariant Covid vaccine). “Researchers at Moderna Inc., Novavax Inc.and the University of Oxford are designing the shots, known as multivalent vaccines”

Safety Results – Winner: Novavax, with less severe adverse events
It is tricky to compare the safety results of the three vaccine manufacturers as there is no standardized reporting method. It would therefore be appropriate to also quote the reported safety results and links to the reports to allow everyone to independently review the results.

The Novavax vaccine safety results were generally better than the results reported by both BioNTech and Moderna. There were no reports of increased severity of side effects between the first and second doses of the Novavax Covid vaccine, though they do report increased incidence. Compare, for instance, the following extracts on adverse events between Novavax, Moderna, and BioNTech.

Novavax
“Unsolicited adverse eventswere predominantly mild in severity... There were no reports of severe adverse events.”

Overall, NVX-CoV2373 recipients reported higher frequencies of solicited systemic adverse eventsthan placebo recipients... Grade 4 systemic adverse events were reported in two NVX-CoV2373 participants after the first dose and in one NVX-CoV2373 participant after the second dose."

"One related serious adverse event was reported in an NVX-CoV2373 recipient (myocarditis), which occurred 3 days after the second dose and was considered a potentially immune-mediated condition; an independent SMC considered the event most likely a viral myocarditis."

Moderna
“The frequency of unsolicited adverse events, unsolicited severe adverse events, and serious adverse events reported during the 28 days after injection was generally similar among participants in the two groups... Bell’s palsy occurred in the vaccine group (3 participants [<0.1%])... In the overall population, the incidence of treatment-related severe adverse events was higher in the mRNA-1273 group (71 participants [0.5%])...”

BioNTech
“Adverse event analysesare provided for all enrolled 43,252 participants... Sixty-four vaccine recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy... Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).”

I believe it is self-evident from the safety reports of Novavax, Moderna, and BioNTech that Novavax generally achieved better safety results and particularly with regards to severe adverse events.

Novavax, however, does not escape the 2nddose increased occurrence of side effects nor does it escape the heart inflammation effect even though “an independent SMC considered the event most likely a viral myocarditis” (see safety report quoted). Novavax has not yet seen its vaccine rolled out on a large scale as has been the case with BioNTech and Moderna, which means it has not yet been tested at that reality level. As mentioned, the 2+2=4 hypothesis discussed above is not proven, yet, but being alert to this development is important to the decision-making on buying, holding, or selling shares in each of the Covid vaccine manufacturers. So, on balance, and with a short head, Novavax wins the safety section.

Efficacy Results – Winner: Novavax
Novavax96.4%

“Demonstrated 100% protection against severe disease.

Confirmed 96.4% efficacy against original strain of COVID-19 and 86.3% efficacy against B.1.1.7 variant strain...

Demonstrated efficacy of 88.9% in adults over the age of 65 and efficacy of 90.9% in adults with high-risk medical comorbidities...

Demonstrated efficacy of 55.4% among HIV-negative participants in South Africa Phase 2b trial, with the vast majority of cases due to the B.1.351 escape variant.”

BioNTech95%

“... demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose.”

Moderna94.1%

“Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100%”

Comment: The Novavax later trials and their participation in the mix-and-match studies have given them access to more diverse data which could be very valuable in designing appropriate booster vaccine candidates, combo candidates, bivalent and multivalent candidates. Participating in the mix-and-match studies also positions them well for the booster shot market.

Stability (Storage & Logistics) – Winner: Novavax
Novavax

“NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.”

BioNTech

"Before mixing, the vaccine may be stored in an ultra-cold freezer between -80°C and -60°C (-112°F and -76°F) (extended periods storage)

Before mixing, the vaccine may be stored in the freezer between -25°C and -15°C (-13°F to 5°F) for up to 2 weeks.

Before mixing, the vaccine may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 1 month (31 days).

Once mixed, vaccine can be left at room temperature (2°C to 25°C [35°F to 77°F]) for up to 6 hours."

Moderna (Slide 11)

“Shipping is in standard freezers (-20°C) and 100 doses in carton to pallet(s) (237,600 doses/pallet)

Storage is up to 6 months in a standard freezer [-25°C and -15°C (-13°F to 5°F)] and 4 weeks at refrigerated temperatures (2-8°C)

Only authorized mRNA vaccine that does not require on-site dilution”

Comment: The stability of the Novavax Covid vaccine is a major competitive advantage.
Conclusion
The market’s over-disappointment with Novavax and unrealistic expectations on manufacturing and filing for US FDA Emergency Use Authorization (EUA) have caused the share price to crash from a high of $331 on 9 February 2021 to a low of $118 on 13 May 2021. It has since recovered some ground but is still badly lagging the share prices of competitors BioNTech and Moderna
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UP $20!!!!!

stonedinvestor · Jun 14, 2021

45,000 bought at 3:54 on a Friday.

Folks I have spotted this a few times in the last week. Each time with my stocks. Some HF is buying in.

SFM-$29

Go to Sprouts go to chart and tic by tic the close on Friday....

stonedinvestor · Jun 14, 2021

Corsair Gaming up about 14% in pre-market as top trending ticker on StockTwits 07:38
CRSR
Shares of Corsair Gaming…

stonedinvestor · Jun 14, 2021

Well, well well....

Marqeta initiated with an Outperform at Autonomous 07:09 MQ Autonomous analyst Craig…

stonedinvestor · Jun 14, 2021

Likewise this CymaBay has popped upon a few of my screens past weeks--

JonesTrading starts CymaBay with Buy, $8 target on seladelpar potential » 06:56 CBAY

stonedinvestor · Jun 14, 2021

CymaBay initiated with a Buy at JonesTrading 06:51 CBAY JonesTrading initiated coverage of CymaBay with a Buy rating and $8 price target.

It all started with this last Wed-

Wednesday

CymaBay to have 'impressive' lineup at EASL meeting, says Piper Sandler 10:42
CBAY
Piper Sandler analyst Yasmeen Rahimi tells investors in a research note that CymaBay will have one of the most impressive lineup at the EASL meeting, with four presentations that bring to light the efficacy and safety of seladelpar in PBC. The analyst, who made no change to her Overweight rating or $12 price target, thinks the company will provide "much-needed education" to increase confidence in enrolling patients in the 52-week, placebo-controlled RESPONSE study.

stonedinvestor · Jun 14, 2021

MQ

ALVR

CBAY

AMMPF

SFM

NVAX

CBAY

stonedinvestor · Jun 14, 2021

vanzandt said:
Stoney!
Happy Sunday night.
A new week dawns.

Hmmmm.
Granny's shorts will be the theme this week.
I already have it picked.

secret
but it closed at $150
A stoney fav to boot.

View attachment 260829

Edit... hey btw Stoney, you spelled Sake wrong. I did too, but only on the cut and paste.
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XPO!! I'm OUT

Also OUT WRAP & INGR

Had to raise money for... MORE TAXES!!!!!!!!!!!