I wouldn’t normally waste your precious life with a full Albert Bourla interview, but his latest delivery at Davos 2022 is spectacularly shameless and delusional.
Here are a couple of short take-outs:
Same clown spilling the beans in another circus arena not long ago:
This falls in line with what the Moderna CEO, Stephane Bancel, has just revealed on the same stage a few days earlier:
All those sitting jabs are billions lives we saved. Something to be proud of. The cherry top is how much we got to them, their amusement while taking on anti-vaxxers is so badly acted it gave Arnold Schwarzenegger the cringe.
Watch the full thing (33min):
Good job convincing people you’re not utter lunatics, boys! Borat called: “great success!”
Meanwhile, Bourla seems to have problems breathing in our atmosphere with his new genetically engineered gills.
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! Articles can always be subject of later editing as a way of perfecting them
The Internets got agitated recently at the news that Moderna’s CEO, Stephane Bancel, dumped $400Million in Moderna stocks and nuked his Twitter account. Here’s why this shouldn’t surprise you and you should expect the worst any moment now.
Developing story, to be updated
Have you watched the former Blackrock director that went on Bannon’s War Room and prophesied that the Covid vaccines are a bubble that’s about to pop? Everything I’ve learned lately stands to support his claim.
This is him on Twitter:
If the dumping were a sudden and unusual move, this would indicate a recent event that shook the system, possibly rats leaving a sinking ship, a near threat for the business, as in:
That’s the case only partly, due to the stock crash overlapped with the incoming financial report, but a constant behavior over the span of months and years rather indicate a strategy and it’s associated with insider trading more often than not.
Surprisingly, it’s NPR of all the fakestream media who came in support of my suspicions, with a pretty merciless analysis of Moderna’s leadership financial behavior. And you know what’s funny? The piece dates all the way back to September 2020. I recommend reading the whole piece, I added the bolding and highlights :
Whether the coronavirus vaccine developed by Moderna succeeds or not, executives at the small biotech company have already made tens of millions of dollars by cashing in their stock. An NPR examination of official company disclosures has revealed additional irregularities and potential warning signs.
“On a scale of one to 10, one being less concerned and 10 being the most concerned,” said Daniel Taylor, an associate professor of accounting at the Wharton School, “this is an 11.”
Taylor said Moderna’s stock-selling practices appear well outside the norm, and raise questions about the company’s internal controls to prevent insider trading.
Since January, CEO Stéphane Bancel has sold roughly $40 million worth of Moderna stock held by himself or associated investment funds; Chief Medical Officer Tal Zaks has sold around $60 million; and President Stephen Hoge has sold more than $10 million.
Stéphane Bancel, chief executive officer of Moderna, has sold roughly $40 million worth of stock in the company since the beginning of this year.
The stock sales first came to widespread notice after Moderna announced positive early data from a vaccine trial in May [2020 – S.m.]. At that point, the company’s share price jumped and official disclosures showed executives cashing in their shares for millions of dollars.
“As long as stocks are sold after public announcements – and not before – one might conclude that for an executive with significant net worth tied up in the company, it’s a prudent thing to do,” said Marc Fagel, a former longtime enforcement official with the Securities And Exchange Commission (SEC). “But the optics aren’t great.”
The Moderna vaccine was quick to reach a phase 3 trial, and is seen as a promising contender. But, in some ways, the executives’ stock sales have overshadowed the company’s progress.
Advocates have questioned whether it’s appropriate for executives to privately profit before bringing the vaccine to market, especially when American taxpayers have committed roughly $2.5 billion to the company’s vaccine development and manufacture.
Here’s what NPR’s examination found:
Stock Sales Worth Tens Of Millions: Since June 1, NPR has found, company executives have sold roughly $90 million worth of Moderna stock. Rather than put a hold on the trades after facing intense criticism in May, company executives continued to sell.
Questionable Modifications To Stock Sale Plans: Moderna says its executives pre-scheduled their stock sales long in advance. Those schedules – known as 10b5-1 plans – can act as a defense to charges of insider trading. But the plans have to be put in place when executives do not have confidential inside information. NPR has found multiple executives adopted or modified their plans just before key announcements about the company’s vaccine. That has raised questions about whether they were aware of nonpublic information when they planned their stock trades.
Selling To Zero: Generally, corporate best practices suggest that a company’s leadership should hold on to at least some stock in their company to have “skin in the game.” That way, the thinking goes, an executive has an incentive to improve the company’s performance. As Moderna has been developing its coronavirus vaccine, two executives, including the Chief Medical Officer, have sold all their stock holdings in the company. The General Counsel has sold nearly all of her holdings.
In an interview with NPR, Ray Jordan, Moderna’s Chief Corporate Affairs Officer, said the company has strict internal policies in place to prevent illegal insider trading. For example, Jordan said, the company only allows employees to make changes to their stock sale schedules when they don’t have confidential inside information that could affect the company’s share price.
NPR asked Jordan why Moderna executives modified their 10b5-1 plans just before major announcements. Initially, Jordan said by email, “I believe you must have your dates wrong.”
NPR then provided documentation of those dates from the company’s official disclosures to the government, which Jordan did not dispute.
Jordan then said that even though multiple Moderna executives changed their 10b5-1 plans within one business day of announcements, the company had determined that those executives did not have “material nonpublic information” – a key term for insider trading – when they made those changes.
A spokesperson for the SEC declined to comment for this story.
From a relative unknown, to a key player in the vaccine race
Moderna launched in 2010 with a headquarters based in Cambridge, Mass., focused on using a technology called messenger RNA (or mRNA) to develop vaccines and therapeutics. The mRNA technology has been widely considered innovative, but remains largely unproven. The company has never brought a product to market. In early January, Moderna was trading for under $20 per share, and was valued at around six billion dollars.
Then Moderna announced that it had started collaborating on a coronavirus vaccine with scientists from the National Institute of Allergy and Infectious Diseases, which is led by Dr. Anthony Fauci.
By April, the government had committed half a billion dollars to the Moderna vaccine project as part of Operation Warp Speed.
Since then, the company’s stock price has exploded. Press releases suggesting positive news from the scientific trials, or announcing additional commitments of taxpayer funding sent the share price to a peak of around $95, before dropping to between $60-$70 in recent months. The company is now valued at around $25 billion.
As a result, shares owned by Moderna executives suddenly became much more valuable. And those executives have cashed in tens of millions of dollars worth of stock, according to filings with the SEC.
The bad press and critical comments did not deter continued sales. Since June 1, NPR found, executives sold around $90 million worth of stock.
Public money, private gain
The U.S. government is making massive financial bets on several vaccine candidates. In all likelihood, only some of those vaccine candidates will prove sufficiently safe and effective.
“If the vaccine doesn’t work, you lost a lot of money,” Fauci has said. “But we feel this is serious enough that it’s worth the financial risk.”
But even if taxpayers lose money betting on Moderna, the company’s executives have already made millions.
“The insiders are making plenty of profit and they’re mostly doing it with our money,” said Margarida Jorge, a campaign director with the group Lower Drug Prices Now. “I’m absolutely for deploying public money in the interests of public health and the public good. But we don’t have any commitment from the administration that any of this investment is ultimately going to benefit real people.”
Moderna has argued that the company was only in a position to work with the government on a coronavirus vaccine, because it had spent a decade developing its mRNA technology with the support of private investors.
“The company has been funded over the years by billions of dollars of private investment,” Zaks told the Freakonomics podcast in August. “Those billions created the opportunity for the U.S. government to come in earlier this year and say, ‘I’m going to add some money to the pot to make sure that you get the development for this vaccine right.'”
[But they locked in the Government and its funding for mRNA technology years before SARS-COV2, as shown below, so this was a deliberate lie – S.m]
“Set it and forget it” stock plans
Moderna has offered another defense of those stock sales: the sales, representatives and executives say, were scheduled well in advance, and were unrelated to the market-moving announcements about the coronavirus vaccine. An NPR examination of the company’s financial filings tells a more complicated story.
The schedules are known as 10b5-1 plans. If your stock trades are on autopilot, the idea goes, then you can’t be accused of insider trading. But these “set it and forget it” plans have to be adopted when executives do not have “material nonpublic information,” to use the legal term.
In an interview with CNBC in July, CEO Bancel said he and other executives set up their 10b5-1 plans “a long time ago” – in December 2018 – and “obviously, when we set up those plans, none of us had any idea what was going to happen in 2020.”
In fact, NPR has found, Moderna executives, including Bancel himself, implemented new plans or modified older plans at multiple points in 2020, and right around key announcements related to the company’s vaccine.
On Jan. 21, 2020, for example, Chief Medical Officer Dr. Tal Zaks amended his 10b5-1 plan. (It’s unclear what changes he made.)
Then, on Jan. 22, Moderna first widely confirmed that it was working with the government on a coronavirus vaccine. The following day, Jan. 23, the company announced it had received additional funding to support its coronavirus vaccine development.
NPR asked Moderna whether Zaks might have been aware of the collaboration with the government when he changed his stock trading plan.
“What was known on that particular day or not known, I couldn’t specifically talk to,” Moderna’s Jordan told NPR. But he said that the Moderna legal team only allows employees to change their 10b5-1 plans if they do not possess inside information that could affect the company’s share price.
Later, on Friday, March 13, three Moderna executives adopted new 10b5-1 plans, according to records reviewed by NPR: Zaks, Chief Technical Operations and Quality Officer Juan Andres, and then-Chief Financial Officer Lorence H. Kim. (Kim left the company in August 2020.)
On Monday, March 16 – one business day later – the company announced that it had given a participant the first dose of their vaccine as part of its phase 1 trial. The stock ended that day up 24% compared to the previous day’s close. Moderna was “bucking the trend” of the broader market, which was panicking over coronavirus fears, one CNBC host said at the time.
Timing Of Changes To Pre-Scheduled Stock Sales Raises Questions
Jan. 21 – Chief Medical Officer Dr. Tal Zaks amends his schedule of stock sales, known as a 10b5-1 plan.
Jan. 22 – Moderna widely confirms that it is working on a coronavirus vaccine with the National Institutes of Health. The company’s share price rises nearly 5% over the previous day’s close.
Jan. 23 – Moderna announces new funding from the Coalition for Epidemic Preparedness Innovations.
Mar. 13 – Chief Technical Operations Officer Juan Andres, Chief Financial Officer Lorence Kim, and Zaks adopt new 10b5-1 trading plans.
Mar. 16 – Moderna announces that it provided the first dose of its coronavirus vaccine to a participant in a phase 1 trial. Moderna stock climbs 24% over the previous day’s close.
May 18 – Moderna reports early positive data from its phase 1 trial. The company’s stock ends the day up 20% over the previous day’s close.
May 29 – Moderna announces another milestone in its phase 2 coronavirus vaccine trial.
June 1 – President Stephen Hoge amends his 10b5-1 plan.
Despite the close timing, Jordan told NPR, “by the judgment of the legal team, there would not have been material, nonpublic information known” when executives entered into the new plans.
“Every company and individual is entitled to the presumption of innocence. That said, from the public’s perspective, this trading behavior looks very problematic,” said Taylor of the Wharton School, who first pointed out the timing of these changes to NPR.
“If I put on my SEC enforcement hat, I would certainly be asking, ‘What caused you to change the plan on a Friday?'” said Kurt Wolfe, who works as a defense attorney in securities cases for the firm Troutman Pepper. “I don’t think it’s a good fact pattern.”
On May 21 – in between announcements of major vaccine trial milestones on May 18 and May 29 – CEO Bancel amended and adopted 10b5-1 plans. And on June 1, President Hoge amended his trading plan.
“Amending a trading plan after a positive announcement, like trading after a positive announcement, is only problematic if the executive possesses material, nonpublic information at the time,” said Fagel. “Though repeated or questionably-timed changes to a trading plan will reduce its value as a defense to insider trading.”
Selling to zero
Using these 10b5-1 plans, two Moderna executives – Zaks and Andres – have sold all of their shares in the company. General Counsel Lori Henderson has sold nearly all of her shares.
In fact, roughly every week since June, Zaks has exercised stock options (meaning, he bought stock at a price set by the company as part of his compensation), and then immediately sold all of his shares for a significant profit.
[Isn’t this a great explanation for Bancel’s sales too?! – S.m]
On Aug. 24, for example, Zaks exercised stock options and bought 25,000 shares at bargain prices of between $12 to $21. He then immediately sold all of those shares for around $65 per share. Zaks ended up with a profit of nearly $1.2 million.
SEC filings indicate these trades are made under the 10b5-1 plan he adopted in March.
Selling so much stock can also raise concerns for investors – and the public – about why company leaders would sell now if they expected their vaccine to succeed later. After all, a safe and effective vaccine could send Moderna’s stock to even greater heights.
“It perhaps draws questions about how much they believe in it,” said Wolfe.
If the company does develop a safe and effective coronavirus vaccine, and its stock keeps rising, then “these trades will be water under the bridge,” said Fagel, the former SEC enforcement official.
But, Fagel warns, if the vaccine fails, then SEC regulators and angry investors may come looking for answers. In that case, he said, “both class action litigation and an SEC investigation would seem inevitable.”
NPR revelations end here, we’re actually just starting
So what we’ve learned is that Moderna looks like a stock market operation more than a medical one. The chiefs create momentums and then trade. And they use public money to bet and make billions, but more about that shortly.
This news is actually pretext to get you to know the real history of Moderna, a crux point in modern history in the widest sense. The stock dumping is not really news, it’s been happening for quite a while, indicating a long term strategy and business model, rather than a sudden or impulse move.
The next two older reports from Pharma’s own media – STAT, will cement the certainty that Moderna turned into a stock market bubble long ago, under the helms of Stephan Bancel. They don’t mind having some science to show, but that’s just the bait.
Ego, ambition, and turmoil: Inside one of biotech’s most secretive startups
At first glance, Moderna Therapeutics looks like the most enviable biotech startup in the world. It has smashed fundraising records and teamed up with pharmaceutical giants as it pursues a radical plan to revolutionize medicine by transforming human cells into drug factories.
But the reality is more complicated.
A STAT investigation found that the company’s caustic work environment has for years driven away top talent and that behind its obsession with secrecy, there are signs Moderna has run into roadblocks with its most ambitious projects.
At the center of it all is Stéphane Bancel, a first-time biotech CEO with an unwavering belief that Moderna’s science will work — and that employees who don’t “live the mission” have no place in the company. Confident and intense, Bancel told STAT that Moderna’s science is on track and, when it is finally made public, that it will meet the brash goal he himself has set: The new drugs will change the world.
But interviews with more than 20 current and former employees and associates suggest Bancel has hampered progress at Moderna because of his ego, his need to assert control and his impatience with the setbacks that are an inevitable part of science. Moderna is worth more than any other private biotech in the US, and former employees said they felt that Bancel prized the company’s ever-increasing valuation, now approaching $5 billion, over its science.
As he pursued a complex and risky strategy for drug development, Bancel built a culture of recrimination at Moderna, former employees said. Failed experiments have been met with reprimands and even on-the-spot firings. They recalled abusive emails, dressings down at company meetings, exceedingly long hours, and unexplained terminations.
At least a dozen highly placed executives have quit in the past four years, including heads of finance, technology, manufacturing, and science. In just the past 12 months, respected leaders of Moderna’s cancer and rare disease programs both resigned, even though the company’s remarkable fundraising had put ample resources at their disposal. Each had been at the company less than 18 months, and the positions have yet to be filled.
Lower-ranking employees, meanwhile, said they’ve been disappointed and confused by Moderna’s pivot to less ambitious — and less transformative — treatments. Moderna has pushed off projects meant to upend the drug industry to focus first on the less daunting (and most likely, far less lucrative) field of vaccines — though it is years behind competitors in that arena.
The company has published no data supporting its vaunted technology, and it’s so secretive that some job candidates have to sign nondisclosure agreements before they come in to interview. Outside venture capitalists said Moderna has so many investors clamoring to get in that it can afford to turn away any who ask too many questions. Some small players have been given only a peek at Moderna’s data before committing millions to the company, according to people familiar with the matter.
“It’s a case of the emperor’s new clothes,” said a former Moderna scientist. “They’re running an investment firm, and then hopefully it also develops a drug that’s successful.”
Like many employees and former employees, the scientist requested anonymity because of a nondisclosure agreement. Others would not permit their names to be published out of fear that speaking candidly about big players in the industry would hurt their job prospects down the road.
Moderna just moved its first two potential treatments — both vaccines — into human trials. In keeping with the culture of secrecy, though, executives won’t say which diseases the vaccines target, and they have not listed the studies on the public federal registry, ClinicalTrials.gov. Listing is optional for Phase 1 trials, which are meant to determine if a drug is safe, but most companies voluntarily disclose their work.
Investors say it’ll be worth the wait when the company finally lifts the veil.
“We think that when the world does get to see Moderna, they’re going to see something far larger in its scope than anybody’s seen before,” said Peter Kolchinsky, whose RA Capital Management owns a stake in the company.
Bancel, meanwhile, said he is aware of the criticism of him and has taken some steps to address it. After scathing anonymous comments about Moderna’s management began showing up online, Bancel went to Silicon Valley to get tips on employee retention from the human resources departments of Facebook, Google, and Netflix. But he makes no apologies for tumult past or present, pointing to the thousands of patients who might be saved by Moderna’s technology.
“You want to be the guy who’s going to fail them? I don’t,” he said in an interview from his glassy third-floor office. “So was it an intense place? It was. And do I feel sorry about it? No.”
An ambitious CEO dreams big
Bancel, 44, had no experience running a drug development operation when one of biotech’s most successful venture capitalists tapped him to lead Moderna. He’d spent most of his career in sales and operations, not science.
But he had made no secret of his ambition.
A native of France, Bancel earned a master’s in chemical engineering from the University of Minnesota and an MBA from Harvard in 2000. As Harvard Business School classmates rushed to cash in on the dot-com boom, Bancel laid out a plan to play “chess, not checkers.”
“I was always thinking, one day, somebody will have to make a decision about me getting a CEO job,” he told an audience at his alma mater in April. “… How do I make sure I’m not the bridesmaid? How do I make sure that I’m not always the person who’s almost selected but doesn’t get the role?”
He went into sales and rose through the operational ranks at pharmaceutical giant Eli Lilly, eventually leading the company’s Belgian operation. And in 2007, at just 34, he achieved his goal, stepping in as CEO of the French diagnostics firm bioMérieux, which employs roughly 6,000 people.
The company improved its margins under Bancel’s tenure, and he developed a reputation as a stern manager who got results, according to an equities analyst who covered bioMérieux at the time.
“He doesn’t suffer fools lightly,” the analyst said, speaking on condition of anonymity to comply with company policy. “I think if you’re underperforming, you’ll probably find yourself looking for another job.”
Bancel’s rise caught the eye of the biotech investment firm Flagship Ventures, based here in Cambridge. Flagship CEO Noubar Afeyan repeatedly tried to entice him to take over one of the firm’s many startups, Bancel said. But he rejected one prospect after another because the startups seemed too narrow in scope.
Moderna was different.
The company’s core idea was seductively simple: cut out the middleman in biotech.
For decades, companies have endeavored to craft better and better protein therapies, leading to new treatments for cancer, autoimmune disorders, and rare diseases. Such therapies are costly to produce and have many limitations, but they’ve given rise to a multibillion-dollar industry. The anti-inflammatory Humira, the world’s top drug at $14 billion in sales a year, is a shining example of protein therapy.
Moderna’s technology promised to subvert the whole field, creating therapeutic proteins inside the body instead of in manufacturing plants. The key: harnessing messenger RNA, or mRNA.
In nature, mRNA molecules function like recipe books, directing cellular machinery to make specific proteins. Moderna believes it can play that system to its advantage by using synthetic mRNA to compel cells to produce whichever proteins it chooses. In effect, the mRNA would turn cells into tiny drug factories.
It’s highly risky. Big pharma companies had tried similar work and abandoned it because it’s exceedingly hard to get RNA into cells without triggering nasty side effects. But if Moderna can get it to work, the process could be used to treat scores of diseases, including cancers and rare diseases that can be death sentences for children.
Bancel was intrigued. He knew it was a gamble, he told STAT, “but if I don’t do it, and it works, I’m just going to kick myself every morning.”
And so he became the company’s CEO — and soon developed an almost messianic reverence for the mRNA technology.
Despite having never worked with RNA before, Bancel said he sat around the table with his core team in the early days of the company, dreaming up experiments. As a result, he is listed as a co-inventor on more than 100 of Moderna’s early patent applications, unusual for a CEO who is not a PhD scientist.
Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine
SAN FRANCISCO — Moderna Therapeutics, the most highly valued private company in biotech, has run into troubling safety problems with its most ambitious therapy, STAT has learned — and is now banking on a mysterious new technology to keep afloat its brash promise of reinventing modern medicine.
Exactly one year ago, Moderna CEO Stéphane Bancel talked up his company’s “unbelievable” future before a standing-room-only crowd at the annual J.P. Morgan Healthcare Conference here. He promised that Moderna’s treatment for a rare and debilitating disease known as Crigler-Najjar syndrome, developed alongside biotech giant Alexion Pharmaceuticals, would enter human trials in 2016.
It was to be the first therapy using audacious new technology that Bancel promised would yield dozens of drugs in the coming decade.
But the Crigler-Najjar treatment has been indefinitely delayed, an Alexion spokeswoman told STAT. It never proved safe enough to test in humans, according to several former Moderna employees and collaborators who worked closely on the project. Unable to press forward with that technology, Moderna has had to focus instead on developing a handful of vaccines, turning to a less lucrative field that might not justify the company’s nearly $5 billion valuation.
“It’s all vaccines right now, and vaccines are a loss-leader,” said one former Moderna manager. “Moderna right now is a multibillion-dollar vaccines company, and I don’t see how that holds up.”
Bancel made no mention of the Crigler-Najjar drug when he spoke Monday before a similarly packed room at this year’s J.P. Morgan conference.
His presentation instead focused on four vaccines that the company is moving through the first phase of clinical trials: two target strains of influenza, a third is for Zika virus, and the fourth remains a secret. Bancel clicked through graphs of data from animal studies before hurrying on to tout Moderna’s balance sheet and discuss the company’s cancer vaccines, slated for clinical testing later this year.
When STAT asked Bancel after the presentation about Crigler-Najjar, he deferred to Alexion.
In need of a Hail Mary
Founded in 2012, Moderna reached unicorn status — a $1 billion valuation — in just two years, faster than Uber, Dropbox, and Lyft, according to CB Insights. The company’s premise: Using custom-built strands of messenger RNA, known as mRNA, it aims to turn the body’s cells into ad hoc drug factories, compelling them to produce the proteins needed to treat a wide variety of diseases.
But mRNA is a tricky technology. Several major pharmaceutical companies have tried and abandoned the idea, struggling to get mRNA into cells without triggering nasty side effects.
Bancel has repeatedly promised that Moderna’s new therapies will change the world, but the company has refused to publish any data on its mRNA vehicles, sparking skepticism from some scientists and a chiding from the editors of Nature.
The indefinite delay on the Crigler-Najjar project signals persistent and troubling safety concerns for any mRNA treatment that needs to be delivered in multiple doses, covering almost everything that isn’t a vaccine, former employees and collaborators said.
The company did disclose a new technology on Monday that it says will more safely deliver mRNA. It’s called V1GL. Last month, Bancel told Forbes about another new technology, N1GL.
But in neither case has the company provided any details. And that lack of specificity has inevitably raised questions.
Three former employees and collaborators close to the process said Moderna was always toiling away on new delivery technologies in hopes of hitting on something safer than what it had. (Even Bancel has acknowledged, in an interview with Forbes, that the delivery method used in Moderna’s first vaccines “was not very good.”)
Are N1GL and V1GL better? The company has produced no data to answer that question. When STAT asked about new technologies, Bancel referred questions to the company’s patent filings.
The three former employees and collaborators said they believe N1GL and V1GL are either very recent discoveries, just in the earliest stages of testing — or else new names slapped on technologies Moderna has owned for years.
“[The technology] would have to be a miraculous, Hail Mary sort of save for them to get to where they need to be on their timelines,” one former employee said. “Either [Bancel] is extremely confident that it’s going to work, or he’s getting kind of jittery that with a lack of progress he needs to put something out there.”
Former employees and collaborators who spoke with STAT requested anonymity because they had signed nondisclosure agreements — which the highly secretive Moderna requires even some job candidates to sign.
A STAT investigation last year found that Bancel had driven away top talent from Moderna with a culture of recrimination and a caustic work environment, including on-the-spot firings for failed experiments.
The company, based in Cambridge, Mass., seems to have repaired its reputation among many rank-and-file employees, winning workplace accolades from Science Magazine and the Boston Globe, but Moderna has lost more than a dozen top scientists and managers in the past four years, despite its vast financial resources.
A bug in the software
Bancel, a first-time biotech CEO, has dismissed questions about Moderna’s potential. He describes mRNA as a simple way to develop treatments for scores of ailments. As he told STAT over the summer, “mRNA is like software: You can just turn the crank and get a lot of products going into development.”
It seems clear, however, that the software has run into bugs.
Patients with Crigler-Najjar are missing a key liver enzyme needed to break down bilirubin, a yellowish substance that crops up in the body as old red blood cells break down. Without that enzyme, bilirubin proliferates in the blood, leading to jaundice, muscle degeneration, and even brain damage.
In Moderna’s eyes, the one-in-million disease looked like an ideal candidate for mRNA therapy. The company crafted a string of mRNA that would encode for the missing enzyme, believing it had hit upon an excellent starting point to prove technology could be used to treat rare diseases.
But things gradually came apart last year.
Every drug has what’s called a therapeutic window, the scientific sweet spot where a treatment is powerful enough to have an effect on a disease but not so strong as to put patients at too much risk. For mRNA, that has proved elusive.
Before COVID-19, the company’s secretive nature, and its failure to deliver a functional product, was drawing comparisons to the infamous biotech startup Theranos. Similar to Moderna, Theranos rarely published any peer-reviewed material. Like Moderna, Theranos mastered the networking game, and recruited high profile individuals to its board in order to vouch for the company’s “revolutionary technologies.” Once valued at well over $10 Billion, Theranos collapsed after it was revealed that the company was running a massive fraud scheme, in addition to its failure to implement its promised blood testing technology.
“Now an obscure lawsuit filed in British Columbia in October sheds light on one of Moderna’s key partners, and through it FORBES can reveal details on Moderna’s amazing but still untested technology.
It appears that the first two products Moderna has entered into clinical trials rely on technology from a small outfit in Vancouver, British Columbia, called Acuitas Therapeutics. (Acuitas is so small, in fact, that its worldwide headquarters are in its CEO’s single-family home.)
Almost all medicines either block proteins–the building blocks of life–or, in the case of expensive biotech drugs, are proteins themselves. But Moderna has been promising to hack an entirely different part of life’s cookbook. In order to turn genetic information encoded in DNA into the cellular machines that actually are proteins, living things use a messenger chemical called mRNA.
Creating these mRNA drugs is a big challenge on many levels. For them to work, Moderna needs to deliver mRNA to the body’s cells. By itself mRNA breaks down in the bloodstream. Tiny Acuitas specializes in one method: lipid-nanoparticle delivery systems. Its technology essentially wraps the mRNA into balls of fat that disguise the drug so that the target cells will readily ingest it.
“Although we are small,” says Thomas Madden, chief executive of Acuitas, “I believe the technology we have developed is highly effective.”
The problem for Madden and Moderna is that Acuitas doesn’t actually own the technology it has licensed to Moderna. The tech belongs to a third company, publicly traded Arbutus, which recently decided to terminate the license for the tech that it had granted to Acuitas. That’s why Acuitas filed the lawsuit in British Columbia, to protect the deal it had. Arbutus immediately countersued, claiming its deal with Acuitas didn’t cover Moderna’s medicines.
The legal mess has its roots in Moderna’s 2011 start, when Robert Langer, an MIT professor, Moderna board member and founder of dozens of biotech companies, told Bancel that Moderna was too underfunded and small to create its own delivery system. So Moderna vetted over a dozen external delivery methods for mRNA and settled on at least three. One belonged to Arbutus, but Moderna turned to tiny Acuitas to get access to it.
Acuitas was formed in 2009 by Madden after a merger eliminated his position at Arbutus’ predecessor, Tekmira Pharmaceuticals. After a contentious lawsuit Madden was able to license from his former employer the novel tech he had helped develop, and Bancel claims Moderna chose to work with Acuitas because it had “the people and the capabilities.”
But that doesn’t explain why Moderna–flush with capital–didn’t make sure that sublicensing through Acuitas would be okay with Arbutus before advancing its new drugs into human studies.
Bancel met with FORBES at a Brooklyn coffee shop on a recent Saturday to dispel the implications of the lawsuit. He is dismissive of Acuitas’ technology. “We knew it was not very good,” he says. “It was just okay.”
He further explains that Moderna is in the process of producing its own nanoparticle lipids. One such lipid, N1GEL (called “Nigel” internally), appears to cause less inflammation than Acuitas’ version. Another is being licensed from Merck. Bancel says Moderna has stopped using the Acuitas tech for new drugs.
That still leaves a somewhat messy situation for any Moderna vaccines that are being developed using Acuitas’ tech.
Data from one vaccine is expected early next year. If results are good, it could lead to a sizzling-hot initial public offering, even if the Canadian lawsuit ultimately affords Arbutus bigger royalty payments from Moderna.”
Well, the two tiny Canadian companies mentioned above bring royalties to the Canada’s treasury (should I say The British Crown?), so don’t expect Trudeau to backpedal too soon
AND IF ONLY THEY HUSSLED WITH PRIVATE FUNDS, AS THEY CLAIMED…
Moderna chief keep claiming that they started to use public funds only as a patch on infrastructure, science and funding they’ve built for years.
It’s known that NIH + NIAID have long been one of their main sources for the “lavish funding” mentioned earlier and when they locked in the government support, they actually started to leverage it and attract even more private funds, in an self-feeding loop that created today’s monster-bubble.
Very few people know they even got money from BARDA and DARPA. As in “military funds”.
Remember this lie from earlier? “The company has been funded over the years by billions of dollars of private investment,” Zaks told the Freakonomics podcast in August. “Those billions created the opportunity for the U.S. government to come in earlier this year and say, ‘I’m going to add some money to the pot to make sure that you get the development for this vaccine right.'” Watch this claim getting nuked:
KEI asks DOD to investigate failure to disclose DARPA funding in Moderna patents
by Knowledge Ecology International (KEI)
Luis Gil Abinader has taken a deep dive into Moderna’s surprising practice of never declaring government funding in its 126 patents and 154 patent applications, despite having had funding from multiple federal agencies.
One outcome of his research is a 25 page report (RN-2020-3) on Moderna’s failure to report funding from DARPA, and a request by KEI to DOD and DARPA to remedy this, including by taking title to patents where disclosures should have been made. (Text of letter below, and PDF version here).
KEI will also send a letter to BARDA. The letter below was addressed to DOD and DARPA, and focuses on their funding.
The obligation to disclose federal funding in patent applications has been subject to presidential executive orders, statutes, regulations and contracts, including those cited and quoted in Abinader’s report. The disclosure clarifies the public’s rights in the inventions and the obligations on the entity getting the money, on everything from the government’s worldwide royalty free license to the public’s march-in rights, obligations to make inventions available to the public on reasonable terms, and additional safeguards that can be exercised by a government inclined to do so.
Secondly, the disclosure changes the narrative about who has financed the inventive activity, often the most risky part of development.
One of the earlier norms on this was Franklin Roosevelt’s Executive Order 9424, on the Establishment of a Register of Government interests in patents.
In 2018, the regulations on disclosure were modified by NIST (see 83 FR 15954), where, among other things, the government gave itself unlimited time to remedy a failure to disclose federal funding, to eliminate one loophole that created an incentive ignore the disclosure requirement.
In the past, the US Department of Defense has taken title to patents where federal funding was not disclosed. See: Campbell Plastics v. Brownlee, 389 F.3d 1243 (Fed. Cir. 2004).
The research on the Moderna/DARPA funding is outlined in a 25 page August 27, 2020 report by Luis Gil Abinader, titled: “Moderna failures to disclose DARPA funding in patented inventions.” RN-2020-3
Below is the text of the KEI letter to Dr. Mark T. Esper, Secretary of Defense, and Dr. Amy Jenkins, of the Pandemic Prevention Platform for the Defense Advanced Research Projects Agency (DARPA), regarding the apparent failure by Moderna to disclose DARPA funding in patent applications. PDF copy here:
2020. September 18. DARPA letter to KEI confirming investigation of Moderna for failure to report government funding in patent applications. https://www.keionline.org/33970
2020. August 4. KEI and Public Citizen request BARDA to address Moderna’s noncompliance with COVID-19 vaccine contract term. https://www.keionline.org/33618
2020. July 1. KEI receives seven new contracts for COVID 19 research from BARDA and DOD, including five using “Other Transactions Authority” that weaken or eliminate Bayh-Dole and FAR Safeguards. https://www.keionline.org/covid19-ota-contracts
Moderna’s vaccine was developed with support from the NIAID, and, as covered in a past fact check, analysis from Axios found that the National Institutes of Health, of which the NIAID is part, may own intellectual property used in producing Moderna’s vaccine. Dr. Francis Collins, director of NIH, has also said that NIH has a stake in intellectual property used in the vaccine, though what exactly this means in practical terms is unclear.
“Valera’s efforts (Moderna subsidiary) have resulted in the demonstration of preclinical efficacy of Moderna’s mRNA-based vaccines in multiple viral disease models, Moderna said.
In the partnership with the Gates Foundation, Valera will apply its mRNA vaccine platform as well as Moderna’s drug platform Messenger RNA Therapeutics™. Designed to produces human proteins, antibodies, and entirely novel protein constructs inside patient cells, the therapeutics are secreted or active intracellularly.” – Genetic Engineering & Biotechnology News
To avoid a conflict of interest, Slaoui resigned from the board of the Massachusetts-based biotech firm Moderna, which had been developing a vaccine for the coronavirus. He stepped down but he didn’t give up his stakes in Moderna, as the Daily Beast reports:
“Slaoui’s ownership of 156,000 Moderna stock options, disclosed in required federal financial filings, sparked concerns about a conflict of interest. Democratic Massachusetts Senator Elizabeth Warren called Slaoui out over the matter on Twitter: “It is a huge conflict of interest for the White House’s new vaccine czar to own $10 million of stock in a company receiving government funding to develop a COVID-19 vaccine. Dr. Slaoui should divest immediately.” The company’s shares skyrocketed last month after news broke of the $483 million in federal funding to work on a coronavirus vaccine. Slaoui could not immediately be reached for comment on the matter.”
Slaoui also sits on the boards of SutroVax, the Biotechnology Innovation Organization, the International AIDS Vaccine Initiative, and the PhRMA Foundation
The circle has just closed. Unless China faked another interview to prop up another myth.
So this has never been about health, just a global scale racketeering operation that’s coming to light about about to go bust. You can speed up this process simply by spreading this expose far and wide!
UPDATE MARCH 21, 2022: VOILA!
Via our ex-BlackRock friend Edward Dowd. I rest my case, but I bet they will “unrest” it soon.
BONUS: MODERNA DIDN’T EVEN CREATE THE SCAM THEY’RE RUNNING
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! Articles can always be subject of later editing as a way of perfecting them