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The Next Biotech Winners After the Vaccine Bubble Burst (ATRX, INMB, DVAX, SAVA, ICPT, IMGN, IBB, MRK, AZN)

The Covid story is starting to change. And you can hear the popping sound in the vaccine space. The needle is “therapeutics”. The therapeutic route was thought to be tricky for this virus on the near-term time horizon, which fueled a massive tsunami…

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2 years ago

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The Covid story is starting to change. And you can hear the popping sound in the vaccine space. The needle is “therapeutics”.

The therapeutic route was thought to be tricky for this virus on the near-term time horizon, which fueled a massive tsunami into the vaccine stocks as large money managers thought they would be the only real option for a long period.

But then along came twin recent breakthroughs in the therapeutics space by Merck & Co., Inc. (NYSE:MRK) and AstraZeneca plc (NASDAQ:AZN), demonstrating clear efficacy in treating Covid after infection in a manner that seems destined to sharply reduce the global rate of new vaccinations ahead – some people just don’t like the idea of getting vaccinated, but they might have bitten the bullet and done it if there was no other option. But suddenly, there are treatments that seemingly remove a big chunk of the worst-case-scenario fear that may have otherwise motivated that difficult decision.

That has caused hemorrhaging outflows from big vaccine players. For biotech investors, the key upshot is a lot of money suddenly roaming around looking for a new home in the biotechnology space.

One area that could benefit is small-cap biotech. As such, we take a look at some of the more interesting names with major growth potential and size them up in light of recent catalysts.

Dynavax Technologies Corporation (NASDAQ:DVAX) operates as a biotech player working to find and produce novel vaccines and immuno-oncology therapeutics. 

The company’s products include HEPLISAV-B, which prevents infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. 

Dynavax Technologies Corporation (NASDAQ:DVAX) recently announced Dynavax has executed an agreement for approximately $22 million over two and a half years to develop a recombinant plague vaccine adjuvanted with CpG 1018®. Under the agreement, Dynavax will conduct a Phase 2 clinical trial combining its CpG 1018 adjuvant with the DOD’s rF1V vaccine. The Company anticipates the Phase 2 trial will commence in 2022.

Ryan Spencer, Dynavax’s Chief Executive Officer commented, “We are honored to receive this award and to support the U.S. government in developing a plague vaccine to protect the U.S. military members who put their lives at risk every day in service to the country. The development of a CpG 1018 adjuvanted plague vaccine is an important example of the broad utility of our adjuvant which we are leveraging to build our pipeline of new and improved vaccines. Our confidence in CpG 1018 is built on the successful development of our FDA-licensed 2-dose adult hepatitis B vaccine and the multiple late-stage COVID-19 vaccine candidates utilizing CpG 1018.”

Even in light of this news, DVAX hasn’t really done much of anything over the past week, with shares logging no net movement over that period. 

Dynavax Technologies Corporation (NASDAQ:DVAX) managed to rope in revenues totaling $52.8M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 1877.8%, as compared to year-ago data in comparable terms. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($345.8M against $204.6M).

Adhera Therapeutics Inc (OTC US:ATRX) may not be a name you have heard of, but that could also be just a matter of time at this point given the strides the company is making in both the Parkinson’s and Diabetes markets. Shares of the stock have been on a tear, up as much as 200% over the past month, but not in a spike or a sudden reactive move. It has been a steady grinding rally.

The gist of the story is that ATRX has licensed two promising compounds, MLR-1019 (armesocarb) and MLR-1023 (tolimidone), from Melior Pharmaceuticals for development, using its own expertise, in the $6 billion underserved Parkinson’s market and the $100-plus billion diabetes market. And the company is seeing progress in its venture as the value of this IP increases.

Adhera Therapeutics Inc (OTC US:ATRX) saw this narrative push a step further recently, announcing that a new European patent has been issued for MLR-1019 (armesocarb), a drug licensed by the Company from Melior Pharmaceuticals. According to its release, Melior has received notice from the European Patent Office that the patent – which is titled, “Methods of Treating Dyskinesia and Related Disorders” – passed the required period without any opposition being filed, triggering the issuance of the patent.

The new patent adds to a growing patent estate protecting MLR-1019 now comprised of 11 issued patents (3 in U.S., Europe Union, Australia, Chinese, Eurasia, Israel, Mexico, South Africa, and Hong Kong) and 8 pending patents (U.S., Japan, Brazil, Canada, 2 in South Korea, New Zealand, and Singapore).

The company’s CEO, Andrew Kucharchuk, noted that, “Given that our development plans for MLR-1019 begin in Eastern Europe, the new patent is particularly timely as part of a robust patent portfolio protecting the intellectual property. Dyskinesias have a negative impact both functionally and socially on most Parkinson’s patients, causing embarrassment while inhibiting their ability for daily tasks, including writing, dressing, and eating. We certainly hope that MLR-1019 can one day provide some relief to this debilitating disease.”

Adhera Therapeutics Inc (OTC US:ATRX) continue to outperform the space. As momentum and crowd awareness build here, the potential for more significant upside is also likely growing given the tiny share float in play for ATRX, with just 13 million shares rattling around on the market.

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) operates as a biopharmaceutical company that engages in the research, development and commercialization of novel therapeutics in treating chronic liver diseases. 

The company’s product pipeline includes OCALIVA which is used for the treatment of biliary cholangitis, nonalcoholic steatohepatitis, sclerosing cholangitis and biliary atresia. 

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) recently announced that it has entered into privately negotiated agreements with certain of the holders of its existing 3.25% Convertible Senior Notes due 2023 (the “2023 Notes”) to repurchase an aggregate of $39.9 million principal amount of 2023 Notes for $38.1 million in cash. The repurchase is expected to close promptly, subject to and following customary closing conditions.

Net of this repurchase and the previously announced convertible notes exchange, Intercept’s 2023 Notes have been reduced from $460.0 million principal balance to $113.7 million principal balance. Jerry Durso, President and Chief Executive Officer, said, “With this repurchase, and our previously announced convertible notes transactions, Intercept has retired over 75% of our 2023 debt maturity obligation. We retain a strong position of cash, cash equivalents, restricted cash and investment debt securities available for sale, and the recent actions to manage our debt obligations will allow us to focus on executing our business plan.”

If you’re long this stock, then you’re liking how the stock has responded to the announcement. ICPT shares have been moving higher over the past week overall, pushing about 21% to the upside on above average trading volume. 

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) managed to rope in revenues totaling $96.6M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 25%, as compared to year-ago data in comparable terms. In addition, the company has a strong balance sheet, with cash levels exceeding current liabilities ($422.5M against $145.3M).

Other key small-cap biotech plays include iShares Biotechnology ETF (NASDAQ:IBB), Cassava Sciences Inc (NASDAQ:SAVA), INmune Bio Inc (NASDAQ:INMB), and ImmunoGen, Inc. (NASDAQ:IMGN).

Please make sure to read and completely understand our disclaimer at https://www.wallstreetpr.com/disclaimer. We may be compensated for posting this content on our website by EDM Media LLC. For questions, comments or suggestions please contact ir@edm.media.

The post The Next Biotech Winners After the Vaccine Bubble Burst (ATRX, INMB, DVAX, SAVA, ICPT, IMGN, IBB, MRK, AZN) appeared first on Wall Street PR.

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Buried Project Veritas Recording Shows Top Pfizer Scientists Suppressed Concerns Over COVID-19 Boosters, MRNA Tech

Buried Project Veritas Recording Shows Top Pfizer Scientists Suppressed Concerns Over COVID-19 Boosters, MRNA Tech

Submitted by Liam Cosgrove

Former…

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4 hours ago

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March 12, 2024

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Buried Project Veritas Recording Shows Top Pfizer Scientists Suppressed Concerns Over COVID-19 Boosters, MRNA Tech

Submitted by Liam Cosgrove

Former Project Veritas & O’Keefe Media Group operative and Pfizer formulation analyst scientist Justin Leslie revealed previously unpublished recordings showing Pfizer’s top vaccine researchers discussing major concerns surrounding COVID-19 vaccines. Leslie delivered these recordings to Veritas in late 2021, but they were never published:

Featured in Leslie’s footage is Kanwal Gill, a principal scientist at Pfizer. Gill was weary of MRNA technology given its long research history yet lack of approved commercial products. She called the vaccines “sneaky,” suggesting latent side effects could emerge in time.

Gill goes on to illustrate how the vaccine formulation process was dramatically rushed under the FDA’s Emergency Use Authorization and adds that profit incentives likely played a role:

"It’s going to affect my heart, and I’m going to die. And nobody’s talking about that."

Leslie recorded another colleague, Pfizer’s pharmaceutical formulation scientist Ramin Darvari, who raised the since-validated concern that repeat booster intake could damage the cardiovascular system:

None of these claims will be shocking to hear in 2024, but it is telling that high-level Pfizer researchers were discussing these topics in private while the company assured the public of “no serious safety concerns” upon the jab’s release:

Vaccine for Children is a Different Formulation

Leslie sent me a little-known FDA-Pfizer conference — a 7-hour Zoom meeting published in tandem with the approval of the vaccine for 5 – 11 year-olds — during which Pfizer’s vice presidents of vaccine research and development, Nicholas Warne and William Gruber, discussed a last-minute change to the vaccine’s “buffer” — from “PBS” to “Tris” — to improve its shelf life. For about 30 seconds of these 7 hours, Gruber acknowledged that the new formula was NOT the one used in clinical trials (emphasis mine):


“The studies were done using the same volume… but contained the PBS buffer. We obviously had extensive consultations with the FDA and it was determined that the clinical studies were not required because, again, the LNP and the MRNA are the same and the behavior — in terms of reactogenicity and efficacy — are expected to be the same.”

According to Leslie, the tweaked “buffer” dramatically changed the temperature needed for storage: “Before they changed this last step of the formulation, the formula was to be kept at -80 degrees Celsius. After they changed the last step, we kept them at 2 to 8 degrees celsius,” Leslie told me.

The claims are backed up in the referenced video presentation:

I’m no vaccinologist but an 80-degree temperature delta — and a 5x shelf-life in a warmer climate — seems like a significant change that might warrant clinical trials before commercial release.

Despite this information technically being public, there has been virtually no media scrutiny or even coverage — and in fact, most were told the vaccine for children was the same formula but just a smaller dose — which is perhaps due to a combination of the information being buried within a 7-hour jargon-filled presentation and our media being totally dysfunctional.

Bohemian Grove?

Leslie’s 2-hour long documentary on his experience at both Pfizer and O’Keefe’s companies concludes on an interesting note: James O’Keefe attended an outing at the Bohemian Grove.

Leslie offers this photo of James’ Bohemian Grove “GATE” slip as evidence, left on his work desk atop a copy of his book, “American Muckraker”:

My thoughts on the Bohemian Grove: my good friend’s dad was its general manager for several decades. From what I have gathered through that connection, the Bohemian Grove is not some version of the Illuminati, at least not in the institutional sense.

Do powerful elites hangout there? Absolutely. Do they discuss their plans for the world while hanging out there? I’m sure it has happened. Do they have a weird ritual with a giant owl? Yep, Alex Jones showed that to the world.

My perspective is based on conversations with my friend and my belief that his father is not lying to him. I could be wrong and am open to evidence — like if boxer Ryan Garcia decides to produce evidence regarding his rape claims — and I do find it a bit strange the club would invite O’Keefe who is notorious for covertly filming, but Occam’s razor would lead me to believe the club is — as it was under my friend’s dad — run by boomer conservatives the extent of whose politics include disliking wokeness, immigration, and Biden (common subjects of O’Keefe’s work).

Therefore, I don’t find O’Keefe’s visit to the club indicative that he is some sort of Operation Mockingbird asset as Leslie tries to depict (however Mockingbird is a 100% legitimate conspiracy). I have also met James several times and even came close to joining OMG. While I disagreed with James on the significance of many of his stories — finding some to be overhyped and showy — I never doubted his conviction in them.

As for why Leslie’s story was squashed… all my sources told me it was to avoid jail time for Veritas executives.

Feel free to watch Leslie’s full documentary here and decide for yourself.

Fun fact — Justin Leslie was also the operative behind this mega-viral Project Veritas story where Pfizer’s director of R&D claimed the company was privately mutating COVID-19 behind closed doors:

Tyler Durden Tue, 03/12/2024 - 13:40

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Association of prenatal vitamins and metals with epigenetic aging at birth and in childhood

“[…] our findings support the hypothesis that the intrauterine environment, particularly essential and non-essential metals, affect epigenetic aging…

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March 12, 2024

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“[…] our findings support the hypothesis that the intrauterine environment, particularly essential and non-essential metals, affect epigenetic aging biomarkers across the life course.”

Credit: 2024 Bozack et al.

“[…] our findings support the hypothesis that the intrauterine environment, particularly essential and non-essential metals, affect epigenetic aging biomarkers across the life course.”

BUFFALO, NY- March 12, 2024 – A new research paper was published in Aging (listed by MEDLINE/PubMed as “Aging (Albany NY)” and “Aging-US” by Web of Science) Volume 16, Issue 4, entitled, “Associations of prenatal one-carbon metabolism nutrients and metals with epigenetic aging biomarkers at birth and in childhood in a US cohort.”

Epigenetic gestational age acceleration (EGAA) at birth and epigenetic age acceleration (EAA) in childhood may be biomarkers of the intrauterine environment. In this new study, researchers Anne K. Bozack, Sheryl L. Rifas-Shiman, Andrea A. Baccarelli, Robert O. Wright, Diane R. Gold, Emily Oken, Marie-France Hivert, and Andres Cardenas from Stanford University School of Medicine, Harvard Medical School, Harvard T.H. Chan School of Public Health, Columbia University, and Icahn School of Medicine at Mount Sinai investigated the extent to which first-trimester folate, B12, 5 essential and 7 non-essential metals in maternal circulation are associated with EGAA and EAA in early life. 

“[…] we hypothesized that OCM [one-carbon metabolism] nutrients and essential metals would be positively associated with EGAA and non-essential metals would be negatively associated with EGAA. We also investigated nonlinear associations and associations with mixtures of micronutrients and metals.”

Bohlin EGAA and Horvath pan-tissue and skin and blood EAA were calculated using DNA methylation measured in cord blood (N=351) and mid-childhood blood (N=326; median age = 7.7 years) in the Project Viva pre-birth cohort. A one standard deviation increase in individual essential metals (copper, manganese, and zinc) was associated with 0.94-1.2 weeks lower Horvath EAA at birth, and patterns of exposures identified by exploratory factor analysis suggested that a common source of essential metals was associated with Horvath EAA. The researchers also observed evidence of nonlinear associations of zinc with Bohlin EGAA, magnesium and lead with Horvath EAA, and cesium with skin and blood EAA at birth. Overall, associations at birth did not persist in mid-childhood; however, arsenic was associated with greater EAA at birth and in childhood. 

“Prenatal metals, including essential metals and arsenic, are associated with epigenetic aging in early life, which might be associated with future health.”

 

Read the full paper: DOI: https://doi.org/10.18632/aging.205602 

Corresponding Author: Andres Cardenas

Corresponding Email: andres.cardenas@stanford.edu 

Keywords: epigenetic age acceleration, metals, folate, B12, prenatal exposures

Click here to sign up for free Altmetric alerts about this article.

 

About Aging:

Launched in 2009, Aging publishes papers of general interest and biological significance in all fields of aging research and age-related diseases, including cancer—and now, with a special focus on COVID-19 vulnerability as an age-dependent syndrome. Topics in Aging go beyond traditional gerontology, including, but not limited to, cellular and molecular biology, human age-related diseases, pathology in model organisms, signal transduction pathways (e.g., p53, sirtuins, and PI-3K/AKT/mTOR, among others), and approaches to modulating these signaling pathways.

Please visit our website at www.Aging-US.com​​ and connect with us:

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Click here to subscribe to Aging publication updates.

For media inquiries, please contact media@impactjournals.com.

 

Aging (Aging-US) Journal Office

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Journal

Aging-US

DOI

10.18632/aging.205602

Method of Research

Observational study

Subject of Research

People

Article Title

Associations of prenatal one-carbon metabolism nutrients and metals with epigenetic aging biomarkers at birth and in childhood in a US cohort

Article Publication Date

26-Feb-2024

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International

A beginner’s guide to the taxes you’ll hear about this election season

Everything you need to know about income tax, national insurance and more.

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4 hours ago

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March 12, 2024

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Cast Of Thousands/Shutterstock

National insurance, income tax, VAT, capital gains tax, inheritance tax… it’s easy to get confused about the many different ways we contribute to the cost of running the country. The budget announcement is the key time each year when the government shares its financial plans with us all, and announces changes that may make a tangible difference to what you pay.

But you’ll likely be hearing a lot more about taxes in the coming months – promises to cut or raise them are an easy win (or lose) for politicians in an election year. We may even get at least one “mini-budget”.

If you’ve recently entered the workforce or the housing market, you may still be wrapping your mind around all of these terms. Here is what you need to know about the different types of taxes and how they affect you.

The UK broadly uses three ways to collect tax:

1. When you earn money

If you are an employee or own a business, taxes are deducted from your salary or profits you make. For most people, this happens in two ways: income tax, and national insurance contributions (or NICs).

If you are self-employed, you will have to pay your taxes via an annual tax return assessment. You might also have to pay taxes this way for interest you earn on savings, dividends (distribution of profits from a company or shares you own) received and most other forms of income not taxed before you get it.

Around two-thirds of taxes collected come from people’s or business’ incomes in the UK.

2. When you spend money

VAT and excise duties are taxes on most goods and services you buy, with some exceptions like books and children’s clothing. About 20% of the total tax collected is VAT.

3. Taxes on wealth and assets

These are mainly taxes on the money you earn if you sell assets (like property or stocks) for more than you bought them for, or when you pass on assets in an inheritance. In the latter case in the UK, the recipient doesn’t pay this, it is the estate paying it out that must cover this if due. These taxes contribute only about 3% to the total tax collected.

You also likely have to pay council tax, which is set by the council you live in based on the value of your house or flat. It is paid by the user of the property, no matter if you own or rent. If you are a full-time student or on some apprenticeship schemes, you may get a deduction or not have to pay council tax at all.

Quarter life, a series by The Conversation

This article is part of Quarter Life, a series about issues affecting those of us in our 20s and 30s. From the challenges of beginning a career and taking care of our mental health, to the excitement of starting a family, adopting a pet or just making friends as an adult. The articles in this series explore the questions and bring answers as we navigate this turbulent period of life.

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Put together, these totalled almost £790 billion in 2022-23, which the government spends on public services such as the NHS, schools and social care. The government collects taxes from all sources and sets its spending plans accordingly, borrowing to make up any difference between the two.

Income tax

The amount of income tax you pay is determined by where your income sits in a series of “bands” set by the government. Almost everyone is entitled to a “personal allowance”, currently £12,570, which you can earn without needing to pay any income tax.

You then pay 20% in tax on each pound of income you earn (across all sources) from £12,570-£50,270. You pay 40% on each extra pound up to £125,140 and 45% over this. If you earn more than £100,000, the personal allowance (amount of untaxed income) starts to decrease.

If you are self-employed, the same rates apply to you. You just don’t have an employer to take this off your salary each month. Instead, you have to make sure you have enough money at the end of the year to pay this directly to the government.

Read more: Taxes aren't just about money – they shape how we think about each other

The government can increase the threshold limits to adjust for inflation. This tries to ensure any wage rise you get in response to higher prices doesn’t lead to you having to pay a higher tax rate. However, the government announced in 2021 that they would freeze these thresholds until 2026 (extended now to 2028), arguing that it would help repay the costs of the pandemic.

Given wages are now rising for many to help with the cost of living crisis, this means many people will pay more income tax this coming year than they did before. This is sometimes referred to as “fiscal drag” – where lower earners are “dragged” into paying higher tax rates, or being taxed on more of their income.

National insurance

National insurance contributions (NICs) are a second “tax” you pay on your income – or to be precise, on your earned income (your salary). You don’t pay this on some forms of income, including savings or dividends, and you also don’t pay it once you reach state retirement age (currently 66).

While Jeremy Hunt, the current chancellor of the exchequer, didn’t adjust income tax meaningfully in this year’s budget, he did announce a cut to NICs. This was a surprise to many, as we had already seen rates fall from 12% to 10% on incomes higher than £242/week in January. It will now fall again to 8% from April.

Read more: Budget 2024: experts explain what it means for taxpayers, businesses, borrowers and the NHS

While this is charged separately to income tax, in reality it all just goes into one pot with other taxes. Some, including the chancellor, say it is time to merge these two deductions and make this simpler for everyone. In his budget speech this year, Hunt said he’d like to see this tax go entirely. He thinks this isn’t fair on those who have to pay it, as it is only charged on some forms of income and on some workers.

I wouldn’t hold my breath for this to happen however, and even if it did, there are huge sums linked to NICs (nearly £180bn last year) so it would almost certainly have to be collected from elsewhere (such as via an increase in income taxes, or a lot more borrowing) to make sure the government could still balance its books.

A young black man sits at a home office desk with his feet up, looking at a mobile phone
Do you know how much tax you pay? Alex from the Rock/Shutterstock

Other taxes

There are likely to be further tweaks to the UK’s tax system soon, perhaps by the current government before the election – and almost certainly if there is a change of government.

Wealth taxes may be in line for a change. In the budget, the chancellor reduced capital gains taxes on sales of assets such as second properties (from 28% to 24%). These types of taxes provide only a limited amount of money to the government, as quite high thresholds apply for inheritance tax (up to £1 million if you are passing on a family home).

There are calls from many quarters though to look again at these types of taxes. Wealth inequality (the differences between total wealth held by the richest compared to the poorest) in the UK is very high (much higher than income inequality) and rising.

But how to do this effectively is a matter of much debate. A recent study suggested a one-off tax on total wealth held over a certain threshold might work. But wealth taxes are challenging to make work in practice, and both main political parties have already said this isn’t an option they are considering currently.

Andy Lymer and his colleagues at the Centre for Personal Financial Wellbeing at Aston University currently or have recently received funding for their research work from a variety of funding bodies including the UK's Money and Pension Service, the Aviva Foundation, Fair4All Finance, NEST Insight, the Gambling Commission, Vivid Housing and the ESRC, amongst others.

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