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Column: A stem cell clinic tees up a Supreme Court challenge to rules protecting patients' health and safety

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Column: A stem cell clinic tees up a Supreme Court challenge to rules protecting patients' health and safety

For years, the Food and Drug Administration has taken up arms against clinics hawking unproven and ineffective stem cell treatments to desperate patients looking for cures of intractable diseases and conditions such as Alzheimer’s, Parkinson’s, multiple sclerosis and even erectile dysfunction.

As the FDA has repeatedly cautioned, there is no scientifically validated evidence that these treatments work. They’re typically not covered by insurance. For the clinics, however, they’re money-makers, with fees of $9,000 or more per treatment; the clinics often recommend multiple treatments.

But now the FDA’s campaign against these bogus therapies is facing serious headwinds on two fronts.

[The FDA is] likely to be subjected to enormous political pressure during Trump 2.0 to weaken oversight of cell and regenerative products.

— Paul S. Knoepfler, UC Davis

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One is the Supreme Court. A California stem cell network that recently lost a lawsuit brought by the FDA has signaled that it intends to appeal to the Supreme Court. It’s far from certain that the court will take up the appeal, at this stage — but a majority of the justices have looked favorably on efforts to rein in administrative agencies such as the FDA.

“I think it’s highly unlikely … but not impossible” that the court will take up the stem cell case, says Henry T. Greely, an expert in the legal issues involving bioscientific technologies.

The case doesn’t have the customary hallmarks of cases that warrant Supreme Court action, Greely told me, such as disagreements among appellate circuits requiring resolution. But it may suit the ideological bent of four justices — the minimum number required to place a case on the Supreme Court docket.

“Some of these justices really hate administrative agency power,” Greely says.

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In a landmark ruling last year, the Supreme Court struck down a 40-year-old precedent—the Chevron doctrine — that required courts to accept federal agencies’ interpretations of the laws they administer as long as their interpretations weren’t openly unreasonable. That sharply narrowed agency authority. The FDA has ranked high on the list of agencies that conservatives see as exercising excessive authority.

It may not take a Supreme Court decision to hamper the FDA’s campaign against bogus stem cell treatments.

“Just the possibility that [the Supreme Court] could take this case may have a chilling effect on FDA activity in the stem cell clinic space,” Paul S. Knoepfler, a UC Davis biologist who has assiduously tracked the industry, told me. Even without the case, he says, the FDA is “likely to be subjected to enormous political pressure during Trump 2.0 to weaken oversight of cell and regenerative products.”

That brings us to the second threat, coming from Donald Trump’s nominee as secretary of Health and Human Services, Robert F. Kennedy Jr. Even before his nomination, Kennedy made clear that he was girding to go to war against the FDA, which would come under his jurisdiction at HHS.

In an Oct. 25 tweet, he declared “FDA’s war on public health is about to end.” He specifically accused the agency of “aggressive suppression” of stem cells as well as “psychedelics, peptides, … raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine … and anything else that advances human health and can’t be patented by Pharma.”

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Kennedy wasn’t clear what he meant by his reference to stem cells or whether he was referring to the unproven stem cell treatments marketed by the clinics facing FDA regulation.

Many of the other items in his litany have been shown to be ineffective for their marketed purposes — ivermectin and hydroxychloroquine, for example, have been touted as treatments for COVID-19 even though scientific studies have shown them to be useless against the disease. I asked Kennedy to clarify his reference to stem cells but haven’t received a reply.

Here’s a brief primer on what these clinics are selling. Typically, their method involves removing fat cells from a customer via liposuction, treating the fat ostensibly to extract stem cells, and injecting those cells into the customer’s body.

For instance, Cell Surgical Network, a defendant in the FDA’s California case, boasts of offering “innovative solutions” for spine disease, knee problems and other orthopedic conditions; lupus, Crohn’s and other autoimmune diseases; ALS, Parkinson’s and multiple sclerosis; cardiac conditions; and glaucoma, among other issues. None of these claims has been supported by scientific research.

The only stem cell products the FDA has approved for use are stem cells extracted from umbilical cord blood, and then only for rare blood disorders.

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Like other clinics, Cell Surgical has asserted that its products are exempt from oversight because, as reimplantations of a customer’s own tissue, they don’t meet the law’s definition of “drugs.”

They also claim the “same surgical procedure” exemption from FDA regulation, which the agency typically applies to procedures in which a patient’s tissue is given only minimal processing before being used, such as in skin grafting or coronary artery bypass surgery. The FDA holds that the stem cell clinics subject the tissues to significant processing and that the procedures are separate surgical events.

Before the FDA acted, both the Florida and California clinic networks had been operating for years. The Florida company had been operating since at least 2014, and Lander and Berman had founded their California Stem Cell Treatment Center in Rancho Mirage in 2010. By 2018, the FDA said in its lawsuit, Lander had claimed that affiliated clinics had administered the technique he and Berman developed to more than 6,000 patients.

Yet the FDA sometimes seems to be fighting a losing battle, or at least a whack-a-mole battle, against clinics offering dubious stem cell treatments. There are just too many — more than 1,000, by Knoepfler’s reckoning — making pitches to desperate customers seeking cures against intractable conditions.

That has left things up to state and local regulators, but the record there is spotty. A notable recent success can be chalked up to Georgia Atty. Gen. Chris Carr, who announced on Jan. 8 that in conjunction with the Federal Trade Commission he had obtained judgments totaling more than $5.1 million from the operators of bogus stem cell clinics. The sum includes refunds of more than $3.3 million for 479 customers, most of whom were “older or disabled adults” who had been “sold expensive, unproven stem cell products.”

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In June 2019, federal Judge Ursula Ungaro of Miami ordered U.S. Stem Cell of Florida effectively shut down, siding with the FDA in a lawsuit the agency had filed in May 2018.

The FDA’s case against California-based Cell Surgical Network and its affiliates took a somewhat different course. The agency filed suit in California federal court against the network and its physician-proprietors, Elliott B. Lander and the late Mark Berman, the same day it sued the Florida firm. But it lost at the trial stage in August 2022, when federal Judge Jesus Bernal of Riverside accepted the defendants’ claim that they were entitled to the “same surgical procedure” exemption from FDA oversight.

Bernal’s decision, however, was overturned last September by the San Francisco-based 9th Circuit Court of Appeals, which found in a 3-0 ruling that the FDA’s interpretation of the law “is the only interpretation that makes sense.” The appeals court sent the case back to Bernal with instructions to reconsider the case in light of its finding.

That’s where things stood until Jan. 6, when Cell Surgical Network and its affiliated defendants asked the appellate court to suspend its order to remand the case to Bernal, pending an appeal to the Supreme Court. The FDA opposed the motion, arguing that the Supreme Court is unlikely to take up the case. The appellate court rejected the network’s motion Tuesday, but the network hasn’t indicated that it intends to drop the Supreme Court appeal. I asked its lawyers if their plans have changed but haven’t received a reply.

As I’ve written before, undermining the FDA’s authority has been a right-wing project for years. That’s because the agency’s duty is to stand in the way of businesses desiring to push unsafe and ineffective nostrums at unwary consumers, and also in the way of a perverse idea that personal freedom includes the freedom to be gulled by charlatans.

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In 2018, then-President Trump signed a right-to-try law that purportedly gave victims of terminal diseases access to experimental treatments that might save them.

But despite claims that it was designed as a “compassionate measure” for terminal patient, the law was a scam perpetrated by the Koch network and its allies, aimed at undermining the FDA’s authority to make sure our drugs are safe and effective. Sen. Ron Johnson (R-Wis.) ultimately gave the game away, informing then-FDA Commissioner Scott Gottlieb, a critic of the law, that its purpose was to “diminish the FDA’s power over people’s lives, not increase it.”

In 2023, GOP-appointed judges on the right wing-dominated 5th Circuit Court of Appeals ruled that the FDA had exceeded its authority in advising against the use of ivermectin against COVID. “The FDA can inform,” the court said, “but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” (Emphasis in the original.)

There may not be much distance between that finding by the 5th Circuit and a decision by the current Supreme Court majority that the FDA overstepped its bounds in not only informing consumers of the dangers of taking unproven and even dangerous stem cell treatments, but blocking the treatments by seeking to put clinics that sell them.

“MAGA loves stem cell clinics,” Greely says. “Why? It gives people a chance to make a lot of money, and because it’s a change for people to say ‘no bureaucrat is going to tell me what to do.’”

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If the trend continues along these lines, you can expect more providers collecting more dollars by pushing worthless therapies to desperate customers. The threat to Americans’ health will be very real indeed.

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Commentary: Trump Media’s financial report revives doubts for investors

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Commentary: Trump Media’s financial report revives doubts for investors

So much Trump-related news has appeared lately on the airwaves and in web pixels — what with Iran and Epstein and Minnesota and so on — that inevitably a nugget will fall between the cracks.

That seems to have been the fate of the most recent annual financial report of Trump Media and Technology Group, which covered calendar year 2025 and was issued Friday.

Trump Media, which is 52% owned by Donald Trump and trades on Nasdaq with a ticker symbol based on his initials (DJT), is the holding company for Trump’s social media platform, Truth Social.

The value of TMTG’s brand may diminish if the popularity of President Donald J. Trump were to suffer.

— A risk factor disclosed by Trump Media

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The annual financial disclosure has garnered minimal press coverage. That’s a pity, because it makes fascinating reading, though not in a good way.

Here are the top and bottom lines from the 10-k annual report: Trump Media lost $712.1 million last year on revenue of about $3.7 million. That’s quite a bit worse than its performance in 2024, when it lost $409 million on revenue of about $3.6 million. The company attributed most of the flood of red ink to “loss from investments,” of which more in a moment.

Truth Social isn’t an especially strong keystone of this operation. The platform is chiefly an outlet for Trump’s social media ramblings and the occasional official White House statements. But no one has to sign in to Truth Social to see them — they’re almost invariably picked up by the news media or reposted by users on other platforms such as X.

That might explain Truth Social’s relatively scrawny user base. The platform is estimated to have about 2 million active users, according to the analytical firm Search Logistics. By comparison, X has about 450 million monthly active users and Facebook has more than 2.9 billion.

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It’s no mystery, then, why TMTG disdains “traditional performance metrics like average revenue per user, ad impressions and pricing, or active user accounts, including monthly and daily active users,” according to its annual report.

Relying on those metrics, which are used to judge TMTG’s social media rivals, “might not align with the best interests of TMTG or its stockholders, as it could lead to short-term decision-making at the expense of long-term innovation and value creation.”

Instead, the company says it should be evaluated based on “its commitment to a robust business plan that includes introducing innovative features, new products, new technologies.” But it also acknowledges that, at its heart, TMTG is a proxy for “the reputation and popularity of President Donald J. Trump.” The company warns that “the value of TMTG’s brand may diminish if the popularity of President Donald J. Trump were to suffer.”

How has that played out in real time? Trump Media notched its highest closing price as a public company, $66.22, on March 27, 2024, the day after its initial public offering. In midday trading Monday, the shares were quoted at $11.08, for a loss of 83% since the IPO.

One can’t quibble with stock market price quotes; nor can one finagle annual profit and loss statements, at least not without receiving questions, and perhaps lawsuit complaints, from attentive investors and the Securities and Exchange Commission.

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In recent months, TMTG has engaged in a number of baroque financial transactions.

In May, the company announced that it was planning to raise $3.5 billion from institutions to invest in bitcoin, with the money to come from issues of common and preferred shares. The goal was to climb onto the cryptocurrency train, which Trump himself was fueling by, among other things, issuing an executive order promoting the expansion of crypto in the U.S. and denigrating enforcement efforts by the Biden administration as reflecting a “war on cryptocurrency.”

Under Trump, federal regulators have dropped numerous investigations related to cryptocurrencies. Trump has also talked about creating a government crypto strategic reserve, which would entail large government purchases of bitcoin and other cryptocurrencies; a March 3 announcement on that subject briefly sent bitcoin prices soaring by nearly 20%, though they promptly fell back.

Then there’s TMTG’s relationship with Crypto.com, a Singapore-based crypto “service provider” best known to Angelenos unfamiliar with the crypto world as the firm with naming rights to the Los Angeles arena that hosts the NBA Lakers and Clippers, WNBA Sparks and NHL Kings.

In August, Crypto.com and TMTG announced a deal in which TMTG would pursue a crypto treasury strategy consisting mostly of Cronos tokens, a cryptocurrency sponsored by Crypto.com. The initial infusion would consist of 6.4 billion Cronos valued at $1 billion, or about 15.8 cents per Cronos.

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As of Dec. 31, TMTG said in its 10-K, it owned 756.1 million Cronos, acquired at a cost of about $114 million, or 15 cents each. By year’s end, they were worth only about nine cents each, for a paper loss of about $46 million. In trading this week, Cronos was quoted at about 7.6 cents, producing a paper loss for TMTG of about $56.5 million, or roughly half the investment.

The financial maneuvering involved in this trade is a little dizzying. The initial transaction was a 50% stock, 50% cash trade in which Crypto.com bought $50 million in TMTG stock and TMTG bought $105 million in Cronos. Who gained in this deal? It’s almost impossible to say.

Crypto.com did gain, if not purely in cash, then arguably through the Trump administration’s good graces.

On March 27, the SEC formally closed an investigation of the company that it had launched during the Biden administration, when the agency was headed by a known crypto skeptic, Gary Gensler. Trump appointed a crypto-friendly regulator, Paul Atkins, as Gensler’s successor.

It’s reasonable to note that as a business model, crypto treasuries have been in vogue over the last year or so, allowing investors to play the crypto market without all the complexities of actually buying and holding the digital assets by buying shares in treasury companies.

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I asked Crypto.com whether the steady decline in Cronos’ price suggested that the hookup with TMTG wasn’t bearing fruit. “The fluctuation in value during this time period is consistent with the entire crypto market, which is typical in a bear market,” company spokeswoman Victoria Davis told me by email.

Davis also asserted that the SEC’s investigation of the company had been closed by Gensler, “not the current administration” (i.e., Trump). That’s misleading, at best. Gensler put the investigation on hold after the 2024 election, when it became clear that Trump was going to be in charge.

Crypto.com’s March 27 announcement of the formal end of the case attributed the action to “the current SEC leadership” and blamed the case on “the previous administration.” I asked Davis to explain the discrepancy but got no reply.

TMTG, like Crypto.com, attributed the decline in Cronos’ value to the secular bear market raging in the entire cryptocurrency space, a reflection of “temporary price swings across the crypto market,” said TMTG spokeswoman Shannon Devine. She said the price decline “will not diminish our enthusiasm for the enormous potential of the [CRONOS] ecosystem.”

Trump’s coziness with crypto companies hasn’t gone unnoticed by Democrats on the House Judiciary Committee, who issued a scathing report on the topic in November. (The White House scoffed at the report, saying in response to the report that Trump “only acts in the best interests of the American public.”)

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In mid-December, TMTG launched yet another remaking — this time, plunging into the business of fusion power. The instrument is TAE Technologies, a Foothill Ranch-based company working to develop the technology of nuclear fusion as a clean energy source. According to a Dec. 18 announcement, TMTG and TAE will merge, creating what they say is a $6-billion company.

According to the announcement, TMTG will contribute $200 million to the merged company when the deal closes in mid-2026, and an additional $100 million subsequently. Following the merger, TMTG said last month, it will consider spinning off Truth Social into a new publicly traded company.

These arrangements are murky. TAE is privately held and the value of Truth Social is conjectural at best, so TMTG shareholders could be hard-pressed to assess their gains or losses from the merger and spin-off.

What makes them even murkier is the speculative nature of fusion as an electrical power source. Although numerous companies have leaped into the field — and TAE, which has been backed by Alphabet, the parent of Google, is among the oldest — none has shown the capability of generating electrical power at commercial scale with the elusive technology.

Although some researchers say that fusion could become a technically and economically feasible power source within 10 years, only in 2022 did fusion researchers (at Lawrence Livermore National Laboratory) achieve the goal of using fusion to produce more energy than is required to sustain a reaction. They were able to do so only for less than a billionth of a second.

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Others working on the technology have expressed doubts that fusion could become a viable power source before the 2040s. The technical challenges, including how to convert the energy produced by a fusion reactor into electricity, remain daunting.

All this points to the fundamental question of what TMTG is supposed to be. TMTG’s original mission, according to its own publicity statements, was to build Truth Social into an alternative social media platform “to end Big Tech’s assault on free speech by opening up the Internet.”

Spinning off Truth Social would place that goal on the side. TMTG is on its way too becoming a hodgepodge of crypto, fusion and other investments selected without regard to whether they fit together or are even achievable. The only constant is Trump himself.

If you want to invest in him, TMTG may be the best way to do it. But judging from its latest financial disclosure, that’s not the same as being a good way to do it.

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California gas is pricey already. The Iran war could cost you even more

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California gas is pricey already. The Iran war could cost you even more

The U.S. attack on Iran is expected to have an unwelcome impact on California drivers — a jump in gas prices that could be felt at the pump in a week or two.

The outbreak of war in the Middle East, which virtually closed a key Persian Gulf shipping lane, spiked the price of a barrel of Brent crude oil by as much as $10, with prices rising as high as $82.37 on Monday before settling down.

The price of the international standard dictates what motorists pay for gas globally, including in California, with every dollar increase translating to 2.5 cents at the pump, said Severin Borenstein, faculty director of the Energy Institute at UC Berkeley’s Haas School of Business.

That would mean drivers could pay at least 20 cents more per gallon, though how much damage the conflict will do to wallets remains to be seen.

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“The real issue though is the oil markets are just guessing right now at what is going to happen. It’s a time of extreme volatility,” Borenstein said. “We don’t know whether the war will widen or end quickly, and all of those things will drive the price of crude.”

President Trump has lauded the reduction of nationwide gas prices as a validation of his economic agenda despite worries about a weak job market and concerns of persistent inflation.

The upheaval in the Middle East could be more acutely felt in the state.

Californians already pay far more for gas than the rest of the country, with the average cost of a gallon of regular at $4.66, up 3 cents from a week ago and 30 cents from a month ago, according to AAA. The current nationwide average is about $3 per gallon.

The disruption in international crude markets also comes as refiners are switching to producing California’s summer-blend gas, which is less volatile during the state’s hot summers. The switch can drive up the price of a gallon of gas at least 15 cents.

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The prices in California are largely driven by higher taxes and a cleaner, less polluting blend required year-round by regulators to combat pollution — and it’s long been a hot-button issue.

The politics were only exacerbated by recent refinery closures, including the Phillips 66 refinery in Wilmington in October and the idling and planned closure of the Valero refinery in Benicia, Calif., which reduced refining capacity in the state by about 18%.

California also has seen a steady reduction in its crude oil production, making it more reliant on international imports of oil and gasoline.

In 2024, only 23.3% of the crude oil refined in the state was pumped in California, with 13% from Alaska and 63% from elsewhere in the world, including about 30% from the Middle East, said Jim Stanley, a spokesperson for the Western States Petroleum Assn.

“We could see a supply crunch and real price volatility” if the Middle East supply is interrupted, he said.

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The Strait of Hormuz in the Persian Gulf, through which about 20% of the world’s oil passes, was virtually closed Monday, according to reports. Though it produces only about 3% of global oil, Iran has considerable sway over energy markets because it controls the strait.

Also, in response to the U.S. attack, Iran has fired a barrage of missiles at neighboring Persian Gulf states. Saudi Arabia said it intercepted Iranian drones targeting one of its refinery complexes.

California Republicans and the California Fuels & Convenience Alliance, a trade group representing fuel marketers, gas station owners and others, have blamed Gov. Gavin Newsom’s policies for driving up the price of gas.

A landmark climate change law calls for California to become carbon neutral by 2045, and Newsom told regulators in 2021 to stop issuing fracking permits and to phase out oil extraction by 2045. He also signed a bill allowing local governments to block construction of oil and gas wells.

However, last year Newsom changed his stance and signed a bill that will allow up to 2,000 new oil wells per year through 2036 in Kern County despite legal challenges by environmental groups. The county produces about three-fourths of the state’s crude oil.

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Borenstein said he didn’t expect that the new state oil production would do much to lower gas prices because it is only marginally cheaper than oil imported by ocean tankers.

Stanley said the aim of the law was to support the Kern County oil industry, which was facing pipeline closures without additional supplies to ship to state refineries.

Statewide, the industry supports more than 535,000 jobs, $166 billion in economic activity and $48 billion in local and state taxes, according to a report last year by the Los Angeles County Economic Development Corp.

Bloomberg News and the Associated Press contributed to this report.

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Block to cut more than 4,000 jobs amid AI disruption of the workplace

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Block to cut more than 4,000 jobs amid AI disruption of the workplace

Fintech company Block said Thursday that it’s cutting more than 4,000 workers or nearly half of its workforce as artificial intelligence disrupts the way people work.

The Oakland parent company of payment services Square and Cash App saw its stock surge by more than 23% in after-hours trading after making the layoff announcement.

Jack Dorsey, the co-founder and head of Block, said in a post on social media site X that the company didn’t make the decision because the company is in financial trouble.

“We’re already seeing that the intelligence tools we’re creating and using, paired with smaller and flatter teams, are enabling a new way of working which fundamentally changes what it means to build and run a company,” he said.

Block is the latest tech company to announce massive cuts as employers push workers to use more AI tools to do more with fewer people. Amazon in January said it was laying off 16,000 people as part of effort to remove layers within the company.

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Block has laid off workers in previous years. In 2025, Block said it planned to slash 931 jobs, or 8% of its workforce, citing performance and strategic issues but Dorsey said at the time that the company wasn’t trying to replace workers with AI.

As tech companies embrace AI tools that can code, generate text and do other tasks, worker anxiety about whether their jobs will be automated have heightened.

In his note to employees Dorsey said that he was weighing whether to make cuts gradually throughout months or years but chose to act immediately.

“Repeated rounds of cuts are destructive to morale, to focus, and to the trust that customers and shareholders place in our ability to lead,” he told workers. “I’d rather take a hard, clear action now and build from a position we believe in than manage a slow reduction of people toward the same outcome.”

Dorsey is also the co-founder of Twitter, which was later renamed to X after billionaire Elon Musk purchased the company in 2022.

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As of December, Block had 10,205 full-time employees globally, according to the company’s annual report. The company said it plans to reduce its workforce by the end of the second quarter of fiscal year 2026.

The company’s gross profit in 2025 reached more than $10 billion, up 17% compared to the previous year.

Dorsey said he plans to address employees in a live video session and noted that their emails and Slack will remain open until Thursday evening so they can say goodbye to colleagues.

“I know doing it this way might feel awkward,” he said. “I’d rather it feel awkward and human than efficient and cold.”

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