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Neuralink logo displayed on a phone screen, a silhouette of a paper in shape of a human face and a binary code displayed on a screen are seen in this multiple exposure illustration photo taken in Krakow, Poland on December 10, 2021.

Jakub Porzycki | Nurphoto | Getty Images

Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday it has received approval from the Food and Drug Administration to conduct its first in-human clinical study.

Neuralink is building a brain implant called the Link, which aims to help patients with severe paralysis control external technologies using only neural signals. This means patients with severe degenerative diseases like ALS could eventually regain their ability to communicate with loved ones by moving cursors and typing with their minds.

“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company wrote in a tweet.

The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The extent of the approved trial is not known. Neuralink said in a tweet that patient recruitment for its clinical trial is not open yet.

Neuralink is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Neuralink is perhaps the best-known name in the space thanks to the high profile of Musk, who is also the CEO of Tesla, SpaceX and Twitter.

Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. But receiving FDA approval for a commercial medical device is no small task — it requires companies to successfully conduct several extremely thorough rounds of testing and data safety collection.

No BCI company has managed to clinch the FDA’s final seal of approval. But by receiving the go-ahead for a study with human patients, Neuralink is one step closer to market.

Neuralink’s BCI will require patients to undergo invasive brain surgery. Its system centers around the Link, a small circular implant that processes and translates neural signals. The Link is connected to a series of thin, flexible threads inserted directly into the brain tissue where they detect neural signals.

Patients with Neuralink devices will learn to control it using the Neuralink app. Patients will then be able to control external mice and keyboards through a Bluetooth connection, according to the company’s website.

The FDA’s approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company. In February, the U.S. Department of Transportation confirmed to CNBC that it had opened an investigation into Neuralink for allegedly packaging and transporting contaminated hardware in an unsafe manner. Reuters reported in March that the FDA had rejected Neuralink’s application for human trials, and reportedly outlined “dozens” of issues the company needed to address.

Neuralink has also come under fire from activist groups for its alleged treatment of animals. The Physician’s Committee for Responsible Medicine, which advocates against animal testing, has repeatedly called on Musk to release details about experiments on monkeys that had resulted in internal bleeding, paralysis, chronic infections, seizures, declining psychological health and death.

A representative for PCRM did not immediately respond to CNBC’s request for comment.

In addition to helping patients with paralysis, experts believe BCIs could someday help treat maladies like blindness and mental illness. Musk has expressed his intent for Neuralink to explore these future use cases, as well as potential applications for healthy people.

At a “show and tell” recruitment event late last year, Musk even claimed he plans to someday receive one of Neuralink’s implants himself.

“You could have a Neuralink device implanted right now and you wouldn’t even know,” Musk said at the time. “In fact, in one of these demos, I will.”

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Samsung Electronics’ operating profit jumps 932.8% in first quarter, beats expectations

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Samsung Electronics' operating profit jumps 932.8% in first quarter, beats expectations

Samsung Electronics Co. Galaxy S24 smartphones during a media preview event in Seoul, South Korea, on Monday, Jan. 15, 2024. Samsung, the world’s most prolific smartphone maker, is leaning into artificial intelligence as the key to unlocking greater sales this year. Photographer: SeongJoon Cho/Bloomberg via Getty Images

SeongJoon Cho | Bloomberg | Getty Images

Samsung Electronics on Tuesday said operating profit for the first quarter jumped 932.8% as memory chip prices rebounded on the back of AI optimism.

Here are Samsung’s first-quarter results versus LSEG estimates:

  • Revenue: 71.92 trillion Korean won (about $52.3 billion), vs. 71.04 trillion Korean won
  • Operating profit: 6.61 trillion Korean won, vs. 5.94 trillion Korean won

Samsung’s revenue for the quarter ending March jumped 12.81% from a year ago, while operating profit soared 932.8% in the same period.

The figures were in line with the company’s guidance earlier this month, where Samsung said operating profit in the January-March quarter likely rose to 6.6 trillion Korean won, up 931% from a year ago. The firm expected first quarter revenue at 71 trillion won.

The South Korean electronics giant saw record losses in 2023 as the industry reeled from a post-Covid slump in demand.

“The company posted KRW 71.92 trillion in consolidated revenue on the back of strong sales of flagship Galaxy S24 smartphones and higher prices for memory semiconductors. Operating profit increased to KRW 6.61 trillion as the Memory Business returned to profit by addressing demand for high value-added products,” Samsung Electronics said in a statement on Tuesday.

Samsung is the world’s largest manufacturer of dynamic random-access memory chips (DRAM), which are commonly found in a wide range of consumer devices including smartphones and computers.

“We assume the earnings surprise was driven by higher memory price hike on AI-driven strong upturn cycle. We anticipate the company will guide for positive memory market outlook and emphasize its readiness in AI era including HBM (12H HBM3E, HBM4) and foundry/packaging solution,” said SK Kim of Daiwa Capital Markets in emailed comments to CNBC on Monday, ahead of the earnings release.

As AI models become more complex and datasets become larger, these models need memory chips with higher capacities and faster speeds to cater to these workloads.

Kim said in an April 5 report he expects another price hike on memory chips to drive Samsung’s second-quarter earnings on the back of an AI boom and the earthquake in Taiwan.

“Especially, we expect more upside in prices resulting from the earthquake in Taiwan,” said Kim, adding that the earthquake in early April temporarily impacted TSMC‘s and Micron‘s production.

Citi analysts said they see upside for Samsung’s NAND flash memory business as a result of AI computing demand. In a note on April 5, they reiterated their “buy” rating on the firm with a target price of 120,000 won — a 56% upside from the closing price of 76,700 won on Monday.

NAND is another staple memory chip alongside DRAM.

“We expect storage (HDD) to be the next bottleneck in AI computing, especially in AI training, and foresee Samsung Electronics to be one of the key beneficiaries of SSD demand momentum for AI training,” said the Citi analysts.

Growing competition

Many countries in the world are racing to manufacture advanced semiconductors.

Earlier this month, the Biden administration agreed to grant Samsung up to $6.4 billion of funding to create new manufacturing capacity to produce chips in Texas. Micron and TSMC are also poised to receive grants to boost chipmaking in the U.S. after decades of chip production moving to Asia.

Samsung and TSMC are set to face competition from Japan’s Rapidus Corporation, which was recently granted $3.89 billion in additional subsidies from the Japanese government to mass produce 2-nanometer chips from 2027.

Samsung has lost its edge, analyst says

There are rising concerns that Samsung Electronics risks losing its leading position to rivals like SK Hynix, the world’s no. 2 memory chip maker.

SK Hynix on March 19 said it became the first in the industry to mass produce HBM3E, the next-generation of high bandwidth memory chips used in AI chipsets. SK Hynix is the primary supplier of HBM3 chips to Nvidia’s AI chipsets.

Mehdi Hosseini, senior tech hardware analyst of Susquehanna International Group, pointed out in early April that Samsung used to be the market leader in memory, smartphones and display innovations.

Now, Samsung is only “benefiting from the cycle recovery,” he added.

In the first quarter, Samsung managed to regain the top spot in smartphone shipments after losing the crown to Apple in 2023, according to International Data Corp.

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Morgan Stanley banker sees 10 to 15 more tech IPOs in 2024, and a ‘better year’ in 2025

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Morgan Stanley banker sees 10 to 15 more tech IPOs in 2024, and a 'better year' in 2025

What's next for the IPO market

Following a long period of waiting, “the IPO market’s back.”

That’s according to Colin Stewart, Morgan Stanley’s global head of technology equity capital markets. In an interview with CNBC’s “TechCheck” on Monday, Stewart said 10 to 15 more tech companies could go public before the end of 2024, with an even “better year” in store for 2025.

“It’s been a long two and a half years, where we’ve had really nothing,” Stewart said. Recent initial public offerings have priced high and traded well, which “bodes well for the future,” he added.

The lull began in 2022, when soaring inflation and rising interest rates pushed investors out of risk, slashed tech valuations and led many tech companies to delay their plans to go public. It was a sharp contrast to the prior two years, which saw a record number of deals, including some at astronomical revenue multiples.

The IPO market cracked open in September, with the debuts of Instacart and Klaviyo. But the first real signs of momentum came last month, as Reddit became the first IPO for a major social media company since Pinterest in 2019 and data center connectivity chip company Astera Labs rocketed on its first day of trading.

Both stocks remain well above their IPO price, with Astera up about 145% as investors pour money into all things tied to artificial intelligence.

Morgan Stanley was the lead banker on the Reddit and Astera IPOs, positioning itself to collect roughly $37 million in total fees.

Wall Street rival Goldman Sachs led the latest venture-backed tech IPO last week. Rubrik, which develops data management software, jumped 16% in its New York Stock Exchange debut.

Bipul Sinha, CEO, Chairman & Co-Founder of Rubrik Inc., the Microsoft backed cybersecurity software startup, waves a flag while posing with employees during the company’s IPO at the New York Stock Exchange (NYSE) in New York City, U.S., April 25, 2024.

Brendan Mcdermid | Reuters

Stewart, who’s had a hand in some of the largest offerings of the last few decades, said it usually takes six months to take an IPO to the finish line. That means companies currently considering an IPO are likely to hold off until 2025 to avoid intersecting with the U.S. presidential election in November, he said.

As for valuations, Stewart said the market has retreated from the peak days of 2021, and multiples in software and other parts of technology are now back to levels seen in 2018 and 2019. Stewart described 2021 as an “amazing year” but also “exhausting.”

“What’s happened in the last six to 12 months is that the market has gotten more comfortable with paying for growth again,” Stewart said. “We’re not back to the levels of 2021, but we are getting a fair price for growth. And I think at those prices, you’re starting to see companies say, ‘You know, it’s actually not bad to be a public company.'”

Still, the most valuable, late-stage companies have yet to hit the exits. That list includes Elon Musk’s SpaceX along with Stripe and Databricks.

While Stewart said he’d “love to take them public,” he acknowledged that the challenge for the bigger names is “they’ve got scale, they’ve got growth, investors are giving them lots of capital” and they’re investing toward the future.

“Right now the IPO is not on their near-term horizon, unfortunately,” he said. “But when it does come they’ll be blockbuster.”

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Embattled grocery startup Getir exits the U.S. and Europe, will refocus on Turkey

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Embattled grocery startup Getir exits the U.S. and Europe, will refocus on Turkey

Companies such as Getir and Gorillas promise to deliver items to shoppers’ doors in as little as 10 minutes.

Angel Garcia | Bloomberg via Getty Images

Grocery delivery startup Getir announced on Monday that it is quitting international markets including the U.K., Germany, the Netherlands and the U.S., marking a major setback for the once hyped online grocery industry.

The Istanbul, Turkey-based firm said in a statement that it was withdrawing from its U.S. and European markets and would now refocus its financial resources on Turkey.

The company said it raised a new investment round led by Abu Dhabi sovereign wealth fund Mubadala and venture capital firm G Squared “to bolster its competitive position in its core food and grocery delivery businesses in Turkey.”

Getir said it generates 7% of its revenues from the U.K., Germany, the Netherlands and the U.S.

“Getir expresses its sincere appreciation for the dedication and hard work of all its employees in the UK, Germany, the Netherlands, and the U.S.,” the company said.

Pandemic grocery hype fades

Struggling space

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