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StockWatch: Illumina Shares Steady as Icahn Escalates Proxy Fight

In his latest open letter to Illumina shareholders, Icahn repeated arguments he has laid out over the past month in past open letters and in interviews….

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Illumina CEO Francis deSouza

The price of Illumina (ILMN) stock has hardly budged this past week, but that calm belies a continuing storm of developments that included a regulatory setback for the sequencing giant and escalating criticism from activist investor Carl Icahn—who yesterday urged the company’s board to fire CEO Francis deSouza.

In his latest open letter to Illumina shareholders, Icahn repeated arguments he has laid out over the past month in past open letters and in interviews. Icahn has faulted Illumina for agreeing to acquire cancer blood test developer Grail for $7.1 billion, then pursuing approvals despite opposition from U.S. and European regulators on antitrust grounds.

Insisting that Illumina’s continuing pursuit of Grail has shrunken its market capitalization by $50 billion, Icahn has announced plans to nominate three allies to the company’s board at its annual meeting. Illumina has rejected the three as lacking the qualifications and experience it seeks in board members, and defended its pursuit of Grail under deSouza.

“We believe the board of directors should dismiss Mr. deSouza immediately and bring back Jay Flatley (or someone else on his level) as CEO,” Icahn wrote.

Flatley is deSouza’s predecessor as CEO, under whom Illumina gained dominance in next-generation sequencing. Under Flatley, Illumina revenues zoomed from just $1.3 million in 2000 to $2.2 billion in 2015. (Illumina finished last year with $4.584 billion in revenue, up 1% from 2021; first quarter results will be released April 25).

Among company milestones Flatley spearheaded was Illumina’s acquiring Solexa in 2006, and its breaking of the $1,000 cost barrier for genome sequencing in 2014, an announcement that electrified the investor crowd attending that year’s J.P. Morgan Healthcare Conference.

Flatley served as CEO from 1999 to 2016, then remained on Illumina’s board for five years as executive chair, and later as chairman until stepping down in 2021. More recently he has helmed the board and served as interim CEO of Zymergen when the previous chief executive quit after unspecified technical problems with its lead product forced the company to walk back earlier rosy revenue predictions—causing a 68% plunge in its share price. Zymergen was acquired by Ginkgo Bioworks last year for $300 million.

Near double compensation

Icahn launched his proxy battle to change Illumina’s board, and thus its direction, last month. That battle expanded into volleys against deSouza last week, after Illumina released its 2023 Proxy Statement showing that deSouza’s total compensation last year nearly doubled, to nearly $27 million from $14.3 million, most of the increase being $12.5 million in stock options.

Activist investor Carl C. Icahn

“Illumina’s board amazingly justified Mr. deSouza’s massive pay increase by saying it was necessary due to the ‘highly competitive talent environment.’ For once we are in complete agreement with this board. It is probably impossible to find a CEO candidate “talented” enough to lose $50 billion of shareholder value in this short a period,” Icahn wrote in a Monday open letter to shareholders. “The more that occurs, the more we realize that something is truly rotten in the state of Illumina.”

Not so, Illumina sought to convey this past week, as it highlighted a pair of recent accomplishments:

  • 200+ Orders: One announcement highlighted how the company had received more than 200 orders for its new NovaSeq X sequencing system in the first quarter. NovaSeq X can generate more than 20,000 whole genomes per year at a cost of $200 per genome, according to Illumina.
  • 25 Years: Another detailed Illumina’s month-long celebration of its 25th anniversary, which the company kicked off on March 30 when a group of its customers, employees, and leaders joined Chief Commercial Officer Susan Tousi to ring the closing bell at the Nasdaq Stock Market in New York’s Times Square.

“We’ve made tremendous progress over the last 25 years, with every discovery bringing us closer to unlocking the power of the genome to improve health—of humans and of the planet,” deSouza said in a statement. “As we celebrate our 25th anniversary, the Illumina family is inspired, energized, and ready to help create the next 25 years of innovation.”

Investors responded to Icahn’s stumping for Jay Flatley by briefly sending Illumina shares up 1% on Wednesday morning, before they finished the day at $230.92, just 0.3% above Tuesday’s close of $230.22—down 56% from the stock’s five-year high of $524.84 reached August 16, 2021 and 22% below the $295.50 price on September 18, 2020, the last trading day before the Grail acquisition was announced, touching off a 12% one-day decline to $270.13.

A group of iIllumina customers, employees, and leaders joined Chief Commercial Officer Susan Tousi to celebrate the company’s 25th anniversary by ringing the closing bell at the Nasdaq Stock Market in New York’s Times Square on March 30. [Nasdaq Inc. via Illumina]
Over the past week, Illumina shares have largely run in place, except for a 1% dip Monday, to $230.02.

FTC orders Grail divestment

The Monday dip came after the U.S. Federal Trade Commission (FTC) ordered the sequencing giant to divest itself of Grail. The FTC concluded in an Opinion and Order that Grail falling under Illumina control “may substantially lessen competition in the relevant United States market for the research, development, and commercialization of MCED tests,” using the acronym for multi-cancer early detection.

The order reversed the decision last September of Chief Administrative Law Judge D. Michael Chappell, who ruled in Illumina’s favor against the FTC challenge to the Grail acquisition.

Illumina said it is appealing the FTC decision, which as a result will stay the agency from carrying out its order. The company is also appealing a European Commission order directing the company to divest itself of the cancer blood test developer. The EC blocked the deal in September 2022, concluding (like the FTC) that the purchase would stifle innovation and reduce choice in the emerging market for blood-based early cancer detection tests. Three months later the Commission issued a Statement of Objections laying out measures to undo the deal.

A final EC decision is expected this spring.

“If Illumina does not prevail in this appeal or the ECJ [European Court of Justice] jurisdictional appeal, the company expects to move expeditiously to divest Grail in a manner that serves the best interests of Illumina’s shareholders,” Illumina stated on Monday.

Icahn called Illumina’s appeals “an almost impossible battle.”

“Our major concern as a large shareholder is that this multi-year battle will consume hordes of cash and go on for years, luxuries that Illumina does not have,” Icahn wrote. “Even in the best case for Mr. deSouza, the ability to own Grail will be a pyrrhic victory, as the core business deteriorates, and customers defect to rival sequencing platforms.”

One analyst agrees with Icahn as to the prospects of Illumina overturning the U.S. and European decisions against the Grail deal, yet still sees upside in Illumina stock. Kyle Mikson, a director and senior equity research analyst with Canaccord Genuity covering the life science tools and diagnostics sector, this week restated the firm’s “Buy” rating for the company’s shares as well as the firm’s 12-month price target of $300 a share—about 30% above where the stock is now trading.

“Although we understand the merits of the Grail business, it appears most investors would prefer the asset to be removed from Illumina,” Mikson wrote in a research note. “We believe ILMN shares will appreciate as the divestiture (which appears highly likely) draws closer.”

Leaders and laggards

  • InflaRx (IFRX) shares nearly tripled, zooming 197% over two days, from $2.05 to $3.77 on Tuesday, then to $6.10 on Wednesday, after the FDA granted emergency use authorization to the company’s first-in-class monoclonal anti-human complement factor C5a antibody Gohibic (vilobelimab). Gohibic was authorized to treat COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation, or extracorporeal membrane oxygenation. The FDA based its decision on Phase III clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically ill invasively mechanically ventilated COVID-19 patients.
  • Liminal BioSciences (LMNL) shares rocketed 86% on Wednesday, from $3.62 to $6.72, after the developer of small molecule therapeutics that modulate G protein-coupled receptor pathways (GPCRs) confirmed receipt of an unsolicited proposal from Structured Alpha—which already owns 64% of Liminal’s shares—to buy the remaining issued and outstanding common shares at $7.50 per share cash. “The Company’s board of directors will review the Proposal to determine the course of action that it believes is in the best interest of the Company,” Liminal stated.
  • OncoSec Medical (ONCS) shares plunged 50% Monday, from $2.58 to $1.30, after the company acknowledged that its lead clinical program assessing TAVO with Merck & Co.’s cancer immunotherapy Keytruda® (pembrolizumab) failed the Phase II KEYNOTE-695 trial (NCT03132675) by missing its primary endpoint of overall response rate (ORR). Among 98 efficacy-evaluable patients with at least one post-baseline tumor assessment, TAVO-EP plus Keytruda achieved ORR of 10.2%; the pre-specified clinically meaningful ORR was ≥17%. OncoSec plans to continue developing the combination in neoadjuvant melanoma, and said it is scheduled to meet with FDA officials in May to discuss a Phase II randomized trial design and future development plans.
  • VBI Vaccines (VBIV) shares plummeted 53%, from 30 cents to 14 cents, on Tuesday after the company announced a restructuring that will eliminate 30-35% of its internal workforce—approximately 60 jobs, based on the 190 full-time and six part-time employees it reported as of December 31, 2022. VBI said it will focus its development efforts on broadening access to its sole marketed product, the FDA-approved 3-antigen hepatitis B virus (HBV) vaccine for adults PreHevbrio [Hepatitis B Vaccine (Recombinant)], and advancing its HBV immunotherapeutic candidate VBI-2601 for chronic HBV. VBI also said it will carry out a 1-for-30 reverse stock split of its issued and outstanding common shares effective April 12.

The post StockWatch: Illumina Shares Steady as Icahn Escalates Proxy Fight appeared first on GEN - Genetic Engineering and Biotechnology News.

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Are Voters Recoiling Against Disorder?

Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super…

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Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super Tuesday primaries have got it right. Barring cataclysmic changes, Donald Trump and Joe Biden will be the Republican and Democratic nominees for president in 2024.

(Left) President Joe Biden delivers remarks on canceling student debt at Culver City Julian Dixon Library in Culver City, Calif., on Feb. 21, 2024. (Right) Republican presidential candidate and former U.S. President Donald Trump stands on stage during a campaign event at Big League Dreams Las Vegas in Las Vegas, Nev., on Jan. 27, 2024. (Mario Tama/Getty Images; David Becker/Getty Images)

With Nikki Haley’s withdrawal, there will be no more significantly contested primaries or caucuses—the earliest both parties’ races have been over since something like the current primary-dominated system was put in place in 1972.

The primary results have spotlighted some of both nominees’ weaknesses.

Donald Trump lost high-income, high-educated constituencies, including the entire metro area—aka the Swamp. Many but by no means all Haley votes there were cast by Biden Democrats. Mr. Trump can’t afford to lose too many of the others in target states like Pennsylvania and Michigan.

Majorities and large minorities of voters in overwhelmingly Latino counties in Texas’s Rio Grande Valley and some in Houston voted against Joe Biden, and even more against Senate nominee Rep. Colin Allred (D-Texas).

Returns from Hispanic precincts in New Hampshire and Massachusetts show the same thing. Mr. Biden can’t afford to lose too many Latino votes in target states like Arizona and Georgia.

When Mr. Trump rode down that escalator in 2015, commentators assumed he’d repel Latinos. Instead, Latino voters nationally, and especially the closest eyewitnesses of Biden’s open-border policy, have been trending heavily Republican.

High-income liberal Democrats may sport lawn signs proclaiming, “In this house, we believe ... no human is illegal.” The logical consequence of that belief is an open border. But modest-income folks in border counties know that flows of illegal immigrants result in disorder, disease, and crime.

There is plenty of impatience with increased disorder in election returns below the presidential level. Consider Los Angeles County, America’s largest county, with nearly 10 million people, more people than 40 of the 50 states. It voted 71 percent for Mr. Biden in 2020.

Current returns show county District Attorney George Gascon winning only 21 percent of the vote in the nonpartisan primary. He’ll apparently face Republican Nathan Hochman, a critic of his liberal policies, in November.

Gascon, elected after the May 2020 death of counterfeit-passing suspect George Floyd in Minneapolis, is one of many county prosecutors supported by billionaire George Soros. His policies include not charging juveniles as adults, not seeking higher penalties for gang membership or use of firearms, and bringing fewer misdemeanor cases.

The predictable result has been increased car thefts, burglaries, and personal robberies. Some 120 assistant district attorneys have left the office, and there’s a backlog of 10,000 unprosecuted cases.

More than a dozen other Soros-backed and similarly liberal prosecutors have faced strong opposition or have left office.

St. Louis prosecutor Kim Gardner resigned last May amid lawsuits seeking her removal, Milwaukee’s John Chisholm retired in January, and Baltimore’s Marilyn Mosby was defeated in July 2022 and convicted of perjury in September 2023. Last November, Loudoun County, Virginia, voters (62 percent Biden) ousted liberal Buta Biberaj, who declined to prosecute a transgender student for assault, and in June 2022 voters in San Francisco (85 percent Biden) recalled famed radical Chesa Boudin.

Similarly, this Tuesday, voters in San Francisco passed ballot measures strengthening police powers and requiring treatment of drug-addicted welfare recipients.

In retrospect, it appears the Floyd video, appearing after three months of COVID-19 confinement, sparked a frenzied, even crazed reaction, especially among the highly educated and articulate. One fatal incident was seen as proof that America’s “systemic racism” was worse than ever and that police forces should be defunded and perhaps abolished.

2020 was “the year America went crazy,” I wrote in January 2021, a year in which police funding was actually cut by Democrats in New York, Los Angeles, San Francisco, Seattle, and Denver. A year in which young New York Times (NYT) staffers claimed they were endangered by the publication of Sen. Tom Cotton’s (R-Ark.) opinion article advocating calling in military forces if necessary to stop rioting, as had been done in Detroit in 1967 and Los Angeles in 1992. A craven NYT publisher even fired the editorial page editor for running the article.

Evidence of visible and tangible discontent with increasing violence and its consequences—barren and locked shelves in Manhattan chain drugstores, skyrocketing carjackings in Washington, D.C.—is as unmistakable in polls and election results as it is in daily life in large metropolitan areas. Maybe 2024 will turn out to be the year even liberal America stopped acting crazy.

Chaos and disorder work against incumbents, as they did in 1968 when Democrats saw their party’s popular vote fall from 61 percent to 43 percent.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Sat, 03/09/2024 - 23:20

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The…

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Department of Veterans Affairs (VA) reviewed no data when deciding in 2023 to keep its COVID-19 vaccine mandate in place.

Doses of a COVID-19 vaccine in Washington in a file image. (Jacquelyn Martin/Pool/AFP via Getty Images)

VA Secretary Denis McDonough said on May 1, 2023, that the end of many other federal mandates “will not impact current policies at the Department of Veterans Affairs.”

He said the mandate was remaining for VA health care personnel “to ensure the safety of veterans and our colleagues.”

Mr. McDonough did not cite any studies or other data. A VA spokesperson declined to provide any data that was reviewed when deciding not to rescind the mandate. The Epoch Times submitted a Freedom of Information Act for “all documents outlining which data was relied upon when establishing the mandate when deciding to keep the mandate in place.”

The agency searched for such data and did not find any.

The VA does not even attempt to justify its policies with science, because it can’t,” Leslie Manookian, president and founder of the Health Freedom Defense Fund, told The Epoch Times.

“The VA just trusts that the process and cost of challenging its unfounded policies is so onerous, most people are dissuaded from even trying,” she added.

The VA’s mandate remains in place to this day.

The VA’s website claims that vaccines “help protect you from getting severe illness” and “offer good protection against most COVID-19 variants,” pointing in part to observational data from the U.S. Centers for Disease Control and Prevention (CDC) that estimate the vaccines provide poor protection against symptomatic infection and transient shielding against hospitalization.

There have also been increasing concerns among outside scientists about confirmed side effects like heart inflammation—the VA hid a safety signal it detected for the inflammation—and possible side effects such as tinnitus, which shift the benefit-risk calculus.

President Joe Biden imposed a slate of COVID-19 vaccine mandates in 2021. The VA was the first federal agency to implement a mandate.

President Biden rescinded the mandates in May 2023, citing a drop in COVID-19 cases and hospitalizations. His administration maintains the choice to require vaccines was the right one and saved lives.

“Our administration’s vaccination requirements helped ensure the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations,” the White House said.

Some experts said requiring vaccination meant many younger people were forced to get a vaccine despite the risks potentially outweighing the benefits, leaving fewer doses for older adults.

By mandating the vaccines to younger people and those with natural immunity from having had COVID, older people in the U.S. and other countries did not have access to them, and many people might have died because of that,” Martin Kulldorff, a professor of medicine on leave from Harvard Medical School, told The Epoch Times previously.

The VA was one of just a handful of agencies to keep its mandate in place following the removal of many federal mandates.

“At this time, the vaccine requirement will remain in effect for VA health care personnel, including VA psychologists, pharmacists, social workers, nursing assistants, physical therapists, respiratory therapists, peer specialists, medical support assistants, engineers, housekeepers, and other clinical, administrative, and infrastructure support employees,” Mr. McDonough wrote to VA employees at the time.

This also includes VA volunteers and contractors. Effectively, this means that any Veterans Health Administration (VHA) employee, volunteer, or contractor who works in VHA facilities, visits VHA facilities, or provides direct care to those we serve will still be subject to the vaccine requirement at this time,” he said. “We continue to monitor and discuss this requirement, and we will provide more information about the vaccination requirements for VA health care employees soon. As always, we will process requests for vaccination exceptions in accordance with applicable laws, regulations, and policies.”

The version of the shots cleared in the fall of 2022, and available through the fall of 2023, did not have any clinical trial data supporting them.

A new version was approved in the fall of 2023 because there were indications that the shots not only offered temporary protection but also that the level of protection was lower than what was observed during earlier stages of the pandemic.

Ms. Manookian, whose group has challenged several of the federal mandates, said that the mandate “illustrates the dangers of the administrative state and how these federal agencies have become a law unto themselves.”

Tyler Durden Sat, 03/09/2024 - 22:10

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

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