Month: August 2022

Powell Says He’s Resolved to Conquer the Mountain of Inflation

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Image Credit: Maureen (Flickr)


Powell Answered the Market’s Three Most Pressing Questions at Jackson Hole Symposium

Federal Reserve Chair Jerome Powell kept his address at Jackson Hole brief and focused. He also gave an intentionally direct message about the current economic environment and his resolve to succeed in changing it.

Powell told his audience, both attendees of the symposium and the broadcast audience, that the monetary policy setting arm of the Fed (FOMC) has as its highest focus to bring inflation back down to its 2% target. Aware that he was speaking to a world audience, he made clear that price stability in the U.S. is the responsibility of the Federal Reserve – and without stable prices, the economy is on shaky ground. He connected low inflation with achieving a sustained period of strong labor markets. Which, alongside inflation, are the mandates of the U.S. central bank. Powell said, “The burdens of high inflation fall heaviest on those who are least able to bear them.”


Is the Fed Okay with a Recession Level Contraction?

He offered that restoring price stability won’t happen in weeks or even months; because it takes time to bring demand and supply into better balance. Is the Fed okay with a recession-level contraction? Powell said, “Reducing inflation is likely to require a sustained period of below-trend growth. Moreover, there will very likely be some softening of labor market conditions.” Powell then explained, “While higher interest rates, slower growth, and softer labor market conditions will bring down inflation, they will also bring some pain to households and businesses.” The Fed Chair said he believes that failing to calm inflation “would mean far greater pain.”


What is the Current State of the U.S. Economy?

Powell believes the economy is showing strong underlying momentum, despite mixed economic numbers. As an example, he said, “The labor market is particularly strong, but it is clearly out of balance, with demand for workers substantially exceeding the supply of available workers.” He added, “Inflation is running well above 2 percent, and high inflation has continued to spread through the economy.” He recognized that July showed an improvement in inflation but said a one-month improvement  “falls far short of what the Committee will need to see.”


What is the Fed Doing to Achieve Balance?

The Fed Chair said they are moving policy to a level that will be restrictive enough to return inflation to 2%. He told listeners that after the last FOMC meeting, they raised the target range for the federal funds rate to 2.25 – 2.5 percent. Powell then offered that with current inflation above 2%, they won’t stop or pause. The estimate is the overnight lending rate, once 2% increases in prices are achieved, is likely to be near the current Fed Funds rate. He recognized that July’s second 75bp increase was large, and under the circumstances, may occur again after the September meeting.

The Fed expects to maintain a restrictive policy stance for some time. He discussed what has happened when the Fed has prematurely eased policy. He offered the FOMC participants’ most recent individual projections from June estimated Fed Funds would run slightly below 4 percent through the end of 2023.

The public’s expectations about future inflation play a role in setting inflation over time. He recognizes that an inflation mentality has not set in, he said, “ But that is not grounds for complacency, with inflation having run well above our goal for some time.”

Powell seemed to want to stress to the markets (bond, stock, real estate), that the Fed plans to do whatever it takes, and it will take a lot. He said he has learned from the mistakes of past Fed chairman, he is being guided by them, and repeatedly expressed his strong resolve to meet the 2% target.

Paul Hoffman

Managing Editor, Channelchek

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Source

https://www.youtube.com/KansasCityFed

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When Corporate Governance Gets Sticky

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Image Credit: NASA HQ Photo (Flickr)


Musk Confounds Experts in Corporate Governance Best Practices

According to the Chartered Governance Institute, “Good quality, ethical decision-making builds sustainable businesses and enables them to create long-term value more effectively.” So it’s no surprise that the head of start-up Neuralink (Elon Musk) has caused so many governance experts to try to wrap their brains around the decision he and a coworker made to have children together.

Often referred to as the richest man in the world, co-founder of Paypal (PYPL), SpaceX owner, Tesla (TSLA) CEO, and Boring Company President, Elon Musk has proven himself successful at managing unique companies through its growth phase. He’s respected worldwide, and a single snarky tweet from the South African-born American is powerful enough to change the fortunes of investors in crypto and some stocks.

Lately, the 51-year-old has been the subject of debate among those that report on company ESG (environmental, social, governance) standards. No, not because he smoked pot on The Joe Rogan Show, although in his role at SpaceX, the government did have some questions. This debate began after he and a direct report at Neuralink became the parents of twins back in November 2021. Neuralink is a less-known Musk creation with about 300 employees. It is developing chips that connect the human brain directly to machines.

The director-level subordinate has reportedly told coworkers that she was not and is not involved romantically with the boss. She has told them the children with Musk were conceived through in-vitro fertilization (IVF).

To avoid possible conflicts of interest, Neuralink’s employee handbook prohibits dating, “personal relationships,” and “close personal friendships” between employees in a direct supervisory dynamic. This is common language in employees’ agreements with their employer. It’s also considered best practice in corporate governance for those in significant management positions. It’s not uncommon for a “fling” to cost a CEO, or subordinate their job. The chief concern is conflicts of interest, putting the company and its investors first.


Musk Again Has Found a Different Path

But the reported circumstances surrounding the Neuralink babies are so unusual that Reuters reached out to corporate governance counselors and asked them to review the company policy and circumstances presented by the two involved. This is clearly a situation with many gray areas. There was no agreement amongst the experts, as with many other things that mix business and personal ethics.

Nell Minow, vice chair of corporate governance consultancy ValueEdge Advisors, told Reuters about the Code of Conduct, “Whatever lawyer wrote this language did not contemplate this situation.” Adding the facts appeared to “fall between the cracks” of the policy’s intent to avoid conflicts of interest due to worker relationships.

Four of the corporate governance experts said they believed the two producing children, even through IVF, is a “personal relationship” or “close friendship,” which Neuralink’s code of conduct requires to be disclosed to a “people operations manager.”  The code does not define a “close friendship” but defines a personal relationship as one where the individuals have a “continuing relationship of a romantic or intimate nature and who are not married to each other.”

Gabriel Rauterberg, a corporate law professor at the University of Michigan, told Reuters, “You’re layering intimate familial bonds over professional relationships,” he explained, “There is always the worry that someone with greater power will use their professional power in ways that are inappropriate.”

The remaining five corporate governance aficionados either did not think the parents’ arrangement was a breach under the Neuralink policy or were stumped by how far outside the box it was for them.

Joan Heminway, a business professor at the University of Tennessee’s law school, pointed out that one can’t demonstrate that the coworkers are close personally, despite the IVF matter, she said, “That’s the new wrench here.”

Usha Rodrigues, a professor at the University of Georgia’s law school, said the matter “may fall under ‘close friendship’ if there is an ongoing, co-parenting type relationship, but that is subject to interpretation.”

 

Business as “Usual”

The extent of Musk’s involvement in the life of his young twins is unclear. A court filing shows they asked for the children to take his last name; the parents also listed the same address in Texas.

Neuralink has accepted the new mom’s description that it is a non-romantic relationship, and she continues in her role as director of operations and special projects. The two still function as a team inside the workplace, each running internal and external meetings. 


Take Away

It’s difficult not to have an opinion on whether non-romantic parenting is an intimate relationship between coworkers or if such a policy is good corporate governance. Perhaps it is a policy that serves one company best yet would be a disaster imposed on another.

We’d like to know what you think. Leave a comment under this article on Channelchek’s Twitter account, and hit the “Follow” button while you’re there.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://www.cgi.org.uk/about-us/policy/what-is-corporate-governance

https://www.reuters.com/business/musk-tests-limits-governance-by-having-children-with-aide-2022-08-26/

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Giving US Citizens Data Privacy Protections

Posted on by Admin 

Image Credit: Anna Alexes (Flickr)


A New US Data Privacy Bill Aims to Give You More Control Over Information Collected About You

A new US data privacy bill aims to give you more control over information collected about you – and make businesses change how they handle data

Data privacy in the U.S. is, in many ways, a legal void. While there are limited protections for health and financial data, the cradle of the world’s largest tech companies, like Apple, Amazon, Google, and Meta (Facebook), lacks any comprehensive federal data privacy law. This leaves U.S. citizens with minimal data privacy protections compared with citizens of other nations. But that may be about to change.

With rare bipartisan support, the American Data and Privacy Protection Act moved out of the U.S. House of Representatives Committee on Energy and Commerce by a vote of 53-2 on July 20, 2022. The bill still needs to pass the full House and the Senate, and negotiations are ongoing. Given the Biden administration’s responsible data practices strategy, White House support is likely if a version of the bill passes.

This article was republished with
permission from The Conversation, a news site dedicated to sharing ideas from
academic experts. It was written by and represents the research-based opinions
of Anne Toomey McKenna, Visiting Professor of Law, University of Richmond.

As a legal scholar and attorney who studies and practices technology and data privacy law, I’ve been closely following the act, known as ADPPA. If passed, it will fundamentally alter U.S. data privacy law.

ADPPA fills the data privacy void, builds in federal preemption over some state data privacy laws, allows individuals to file suit over violations and substantially changes data privacy law enforcement. Like all big changes, ADPPA is getting mixed reviews from media, scholars and businesses. But many see the bill as a triumph for U.S. data privacy that provides a needed national standard for data practices.

 

Who and What will ADPPA Regulate?

ADPPA would apply to “covered” entities, meaning any entity collecting, processing or transferring covered data, including nonprofits and sole proprietors. It also regulates cellphone and internet providers and other common carriers, with potentially concerning changes to federal communications regulation. It does not apply to government entities.

ADPPA defines “covered” data as any information or device that identifies or can be reasonably linked to a person. It also protects biometric data, genetic data and geolocation information.


Protected data includes your location – Southernmost House, Key West (C. Watts, Flickr)

The bill excludes three big data categories: de-identified data, employee data, and publicly available information. That last category includes social media accounts with privacy settings open to public viewing. While research has repeatedly shown deidentified data can be easily reidentified, the ADPPA attempts to address that by requiring covered entities to take “reasonable technical, administrative, and physical measures to ensure that the information cannot, at any point, be used to re-identify any individual or device.”

 

How ADPPA Protects Your Data

The act would require data collection to be as minimal as possible. The bill allows covered entities to collect, use or share an individual’s data only when reasonably necessary and proportionate to a product or service the person requests or to respond to a communication the person initiates. It allows collection for authentication, security incidents, prevention of illegal activities or serious harm to persons, and compliance with legal obligations.

People would gain rights to access and have some control over their data. ADPPA gives users the right to correct inaccuracies and potentially delete their data held by covered entities.

The bill permits data collection as part of research for public good. It allows data collection for peer-reviewed research or research done in the public interest – for example, testing whether a website is unlawfully discriminating. This is important for researchers who might otherwise run afoul of site terms or hacking laws.

The ADPPA also has a provision that tackles the service-conditioned-on-consent problem – those annoying “I Agree” boxes that force people to accept a jumble of legal terms. When you click one of those boxes, you contractually waive your privacy rights as a condition to simply use a service, visit a website or buy a product. The bill will prevent covered entities from using contract law to get around the bill’s protections.


Looking to Federal Electronic Surveillance Law for Guidance

The U.S.’s Electronic Communications Privacy Act can provide federal law makers guidance in finalizing ADPPA. Like the ADPPA, the 1986 ECPA legislation involved a massive overhaul of U.S. electronic privacy law to address adverse effects to individual privacy and civil liberties posed by advancing surveillance and communication technologies. Once again, advances in surveillance and data technologies, such as artificial intelligence, are significantly affecting citizens’ rights.

ECPA, still in effect today, provides a baseline national standard for electronic surveillance protections. ECPA protects communications from interception unless one party to the communication consents. But ECPA does not preempt states from passing more protective laws, so states can choose to provide greater privacy rights. The end result: Roughly a quarter of U.S. states require consent of all parties to intercept a communication, thus providing their citizens increased privacy rights.

ECPA’s federal/state balance has worked for decades now, and ECPA has not overwhelmed the courts or destroyed commerce.

 

National Preemption

As drafted, ADPPA preempts some state data privacy legislation. This affects California’s Consumer Privacy Act, although it does not preempt the Illinois Biometric Information Privacy Act or state laws specifically regulating facial recognition technology. The preemption provisions, however, are in flux as members of the House continue to negotiate the bill.

ADPPA’s national standards provide uniform compliance requirements, serving economic efficiency; but its preemption of most state laws has some scholars concerned, and California opposes its passage.

If preemption stands, any final version of the ADPPA will be the law of the land, limiting states from more firmly protecting their citizens’ data privacy.


Private Right of Action and Enforcement

ADDPA provides for a private right of action, allowing people to sue covered entities who violate their rights under ADPPA. That gives the bill’s enforcement mechanisms a big boost, although it has significant restrictions.

The U.S. Chamber of Commerce and the tech industry oppose a private right of action, preferring ADPPA enforcement be restricted to the Federal Trade Commission. But the FTC has far less staff and far fewer resources than U.S. trial attorneys do.

ECPA, for comparison, has a private right of action. It has not overwhelmed courts or businesses, and entities likely comply with ECPA to avoid civil litigation. Plus, courts have honed ECPA’s terms, providing clear precedent and understandable compliance guidelines.


How Big are the Changes?

The changes to U.S. data privacy law are big, but ADPPA affords much-needed security and data protections to U.S. citizens, and I believe that it is workable with tweaks.

Given how the internet works, data routinely flows across international borders, so many U.S. companies have already built compliance with other nations’ laws into their systems. This includes the E.U.’s General Data Protection Regulation – a law similar to the ADPPA. Facebook, for example, provides E.U. citizens with GDPR’s protections, but it does not give U.S. citizens those protections, because it is not required to do so.

Congress has done little with data privacy, but ADPPA is poised to change that.


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Time is Running Out for US and EU Firms to Synch with MiFIDII

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Image Credit: Pixabay (Pexels)


Securities Industry Has Less than a Year to Comply with Rules Regarding Research

On July 4, 2023, the European and U.S. financial regulatory bodies could be at odds with each other’s rules. The reason is a simple difference in how each believes compensation should be paid to brokers providing research on securities to clients. The conflict stems from a four-year-old rule instituted in the EU. At the time, it would have impacted U.S. securities brokers, but the SEC temporarily relieved the problem by signing a no-action letter saying they would not enforce the problematic areas immediately. The SEC no-action letter expires on July 3 of next year – the Commission has just indicated they will not renew it. This could create a very expensive problem for many U.S. brokers while leaving investors based out of the EU scrambling to locate institutional quality research. It could also mean fewer companies will get the attention they were once receiving as the information will not be distributed to EU buy-side shops. Worse yet, some of these companies covered by broker analysts may lose all sell-side research of their companies.


Specifics

In 2018 the EU created a rule whereby cost or fees associated with research provided to the buy-side had to be accounted for separately from transactional business income. It’s called The EU Markets in Financial Instruments Directive II (“MiFID II”), the effective date was January 3, 2018. That seems harmless enough; a broker can not provide “free” research to customers; they would need to charge them separately. However, in the US, if a broker or anyone else provides investment advice for a fee, they need to be licensed as an investment advisor. While securities brokers have licenses, this additional registration would change the framework of recordkeeping and allowed activities.

Brokers facilitate trades and are not permitted under their registration to recommend trades. Investment advisors can make specific recommendations. These are very distinct roles in a related field. Investment advisors are clients of brokerage firms.

U.S. registered broker/dealers have had an exception from the definition of investment adviser under the Advisers Act (in respect of research distribution). In the U.S., distribution of research must be advice incidental to the firm’s broker-dealer business, and the broker-dealer does not receive “special compensation.” If the broker gets paid to provide research (hard dollar payment) the SEC considers this “special compensation” for investment advice.

The EU, as of 2018, required a separate breakout fee associated with the “advice.” A separate breakout fee in the states would force the broker to reregister as an advisor if hard dollar compensation is exchanged.


Why is this Suddenly a Problem?

You could blame it on Covid, blame it on disbelief, blame it on forgetfulness, but the SEC issued a no-action letter to the Securities Industry and Financial Markets Association (SIFMA). The letter was renewed in 2020 to expire in July of next year. The essence of the letter is: It would not recommend enforcement action to broker/dealers accepting cash payments for research from investment managers who are required by Mifid II to pay for research with their own money as opposed to client commissions or soft dollars. This was even better for broker/dealers as they began charging these overseas clients or shrunk their research universe.

The original end date of the no-action stipulation was July 3, 2020. It had been extended for three years in order to allow more time for broker-dealers to alter their business to either receive compensation for research services or cease providing it, at least to EU clients.

A Director of the SEC Division of Investment Management recently indicated in a speech that after July 3, 2023, U.S. broker-dealers accepting MiFID II compensation can no longer rely on the no-action letter to escape classification as an investment adviser. The letter will not be renewed as many expected.


Take Away

Equity research, particularly on small and mid-size companies, is important for the buy-side investor, it’s a well-entrenched sales tool for brokers and is important to the covered companies that information is available for investors to better understand their business and outlook. In less than a year, the SEC will expect any broker offering research for pay (as required under MiFID II) to register as an investment adviser. Doing so would be very difficult for much of the U.S. brokerage community. 

Other providers of research include Independent Research (IRP), most often paid for by the investor, and Company Sponsored Research (CSR), where the analyst coverage is paid for by the covered company.  

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://substantiveresearch.com/matter/substantive-research-survey-reveals-60-of-asset-managers-will-not-change-investment-research-processes/

https://www.evalueserve.com/blog/us-firms-need-mifid-ii-compliance/

https://www.kslaw.com/news-and-insights/broker-dealer-research-mifid-related-hard-dollar-sec-investment-adviser-status-relief-to-end-in-july-2023

https://www.investopedia.com/terms/m/mifid-ii.asp

https://www.irmagazine.com/regulation/week-investor-relations-buy-side-impact-sec-mifid-decision-no-good-or-bad-investments

https://www.thetradenews.com/sec-decides-not-to-extend-research-services-enforcement-no-action-letter-to-sifma/

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Should Investors Pay Attention to US Strategic Reserve Replenishment?

Posted on by cpatches
Image Credit: Paul B (Flickr)

Will Drivers Continue to be Dogged by High Gas Prices as US Strategic Oil Reserve is Replenished?

The last time the US Strategic Oil Reserves was this low was January 1985. The US population was then 238 million, The Cosby Show was the top-rated on TV, the threat of the AIDS virus was just beginning to be understood, and a newly appointed NIH Director named Anthony Fauci had just been promoted. In 37 years, some things have changed, and some things have not. One that has not is the need for reliable energy.

The Reserves reached its peak in April 2011 with 726.5 million barrels; today we sit with 453.1 million. Will it take 37 years to replenish the more than 200 million barrels, 160 million that have been siphoned off since March of this year?


The barrels that are being used in 2022, were ordered released by the White House to offset domestic loss of production, pipeline distribution, and less supply compounded by global shortages resulting from a partial embargo against Russia. The order is intended to work to lower gas prices today and help reduce the impact oil prices are having on unacceptably high inflation.

President Biden said in March that the US would release one million barrels of oil a day for six months as petroleum products spiked following the start of the Russian/Ukrainian war. The White House then said, in late July, the US would release another 20 million barrels.

To some degree, it worked as intended. There has been a fall in the price at the gas pumps over the past two months. Much of this has been supply related helped by the reserve releases, and to a lesser extend, demand has also slowed from receding economic activity. WTI crude, the US benchmark price, has dropped around 24%.


That decline has brought US gasoline prices down from above $5 a gallon in June to $3.89 on Tuesday, August 17. Globally, other countries are tapping into their own strategic reserves as well.

What Happens When we Refill It?

The US consumed about 20 million barrels of oil a day on average in 2021, according to the EIA. During the same year, it produced 11 million barrels a day. The Biden administration is proposing to refill the stockpiles under a plan that is likely to see it order 60 million barrels this fall for delivery at an unspecified time in the future. That leaves at least another 100 million barrels to bring the country back to where we were in March 2022 – over two hundred more to bring us back to the peak. It took 37 years last time for the country to stockplile the same amount.

The current infrastructure is not supporting additional oil output, or companies would be pumping now. On July 1, President Biden made public a five-year proposal for offshore oil and gas development in areas of existing production and said the final plan might have anywhere from zero to 11 lease sales.

The range of proposed options were, between two auctions a year and none at all. The plan seemed conflicted with a desire to balance the administration’s efforts to reduce the use of fossil fuels and its calls to increase needed oil and gas.

Energy Demand Moving Forward

Does restocking the Reserves point toward high petroleum demand for a much longer time period than ever expected? Does it also create opportunities for producers of biofuels, for example GEVO?

The current fuel issues are not going to disappear overnight. Borrowing from the future with an intent, and now a plan to pay it back, will require more production than before. Companies that produce are not inclined to make big investments in building out a platform when the political climate is one of wanting to shut production down as soon as possible.

The cost of reducing energy output and then borrowing from reserves, especially when an unexpected embargo is placed on a major supplier, could keep the price of all energy elevated for a much longer time than, the end of a war, of installation of coastal wind farms.

Paul Hoffman

Managing Editor, Channelchek 

Sources

https://www.eia.gov/dnav/pet/hist/LeafHandler.ashx?n=PET&s=MCSSTUS1&f=M

https://www.eia.gov/petroleum/gasdiesel/gas_geographies.php#pricesbyregion

https://www.whitehouse.gov/briefing-room/statements-releases/2022/07/26/fact-sheet-department-of-energy-releases-new-notice-of-sale-as-gasoline-prices-continue-to-fall/

https://www.niaid.nih.gov/about/director

https://www.energy.gov/articles/doe-announces-additional-notice-sale-crude-oil-strategic-petroleum-reserve

https://www.reuters.com/business/energy/biden-administration-proposes-offshore-drilling-plan-focused-mainly-us-gulf-2022-07-01/

What Signs Will Investors Get from Powell at Jackson Hole

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Image Credit: Steve Jurvetson (Flickr)


What is the Jackson Hole Symposium and Why it’s Important to Investors?

With almost a month to go before the next FOMC meeting, investors have set their focus on the Jackson Hole Economic Symposium – the conference organized each year by the Kansas City Federal Reserve Bank. Last
year’s symposium (held online for attendees) allowed the Fed Chair to recap the challenges of the previous 12 months of pandemic management. One Powell utterance that was mostly overlooked last year was his comment on inflation when he pointed out that demand was outstripping pandemic-reduced supply. He said it was a big factor in why inflation was running ahead of the Fed’s 2% target. One year later, inflation is likely to be the most discussed topic, and market participants and others interested in the economy will be listening intently to how strongly the U.S. Central Bank will need to squelch growth to bring damaging inflation down.


About the Jackson Hole Event

The Kansas City Fed has been hosting the annual conference to discuss the economy since 1982 at a lodge in Grand Teton National Park. The attendees are central bankers from around the world, economists from the 12 Federal Reserve Districts, academics, influential economic leaders, policymakers, and journalists.


Image: Jackson Hole Symposium attendance (Kansas City Federal Reserve)

Each year there is a theme. For example, “Guided by
the Stars” in 2018 set the tone for the year’s whitepapers and speeches the event is known for. Powell’s 2018 address is considered his most memorable. It outlined how he thinks about critical but unmeasurable variables like the natural rate of interest (R-star) and the natural rate of unemployment (U-star). For 2022 the theme is “Reassessing Constraints on the Economy
and Policy.” To be sure, the world will be listening – so far this decade, Central Banks have seemed to push the barriers of previously believed boundaries and constraints on policy. There will also be a number of whitepapers made public on the subject; these will be released Thursday evening. Powell’s speaking slot is first thing Friday (10 am EDT)

The presentations and discussions are not broadcast (except for Powell’s speech this year), but all of the proceedings in the room are on the record, and economic journalists are on hand to report what they hear. The Kansas City Fed publishes the papers on its website.


Powell’s Words

One of the most powerful market-moving things a Fed Chair can do is talk. Every word of his speech will be scrutinized; they know this, so they choose their words wisely. Traditionally, the Fed chair uses the Jackson Hole speech to deliver a particularly important and long-range message, similar to a president’s State of the Union.

It is highly unlikely he will give any guidance as to what he is doing next month. Instead, he’ll be recognizing paths and cultivating an understanding of changes in the economic climate and policies to foster desired long-term results.  


Is it all Business?

In the early 1980s, the Kansas City Fed leaders learned that the best way to ensure Fed chairman Paul Volcker would accept an invitation was to locate the event somewhere with good fly fishing in late August. Jackson Hole was it!

It also helps that the late summer ski resort setting is gorgeous. The weather is usually great, and the Kansas City Fed has done a commendable job cultivating compelling topics, papers, and guest lists over the years.

The eventgoers are not surrounded by luxury. Rather, it’s at a lodge in a national park that remains open to the public. It features a big grizzly bear trophy in the lobby. The rooms are rustic.

In and around the conference, it is common to see powerful economic policymakers from around the world wandering the hotel lobby, along with American tourists who drove in an RV or a group of motorcycles.

Some symposium attendees adopt Western fashion, wearing cowboy hats, boots, and pearl snap shirts. Others find more traditional business casual more their flavor. After the second day of economic meetings, attendees usually go to a Friday dinner with Western-themed entertainment, such as a horse whisperer.


Take Away

Four decades after the first Jackson Hole Economic Symposium, it is an important event for those in the meetings and an important event for those with a stake in the U.S. economy. History is made at these meetings as subtle shifts have a big impact on the future wealth of the nation. The mountain resort lends itself to a relaxed feel. Behind closed doors at the symposium itself, the small amount of attendees is closer than at many economic conferences.

Beginning at 10 am EDT tomorrow, the markets will have their answer as to what the Fed Chair will say. If it is in line with his more recent comments, he will place inflation as a priority and word it in a way where it is understood but not feared by those with business interests.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://www.kansascityfed.org/research/jackson-hole-economic-symposium/about-jackson-hole-economic-symposium/

https://www.cnbctv18.com/economy/jackson-hole-symposium-2022-all-eyes-on-us-fed-chair-jerome-powell-expectations-explained-14583021.htm

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Great Lakes Dredge & Dock (GLDD) – More Awards, More Work

Posted on by Admin

Thursday, August 25, 2022

Great Lakes Dredge & Dock (GLDD)
More Awards, More Work

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

More Awards Announced. Great Lakes Dredge & Dock announced yesterday the Company has received eight new awards that total $107.0 million, with the awards to be completed by the end of the fiscal 2022 year through the second half of the 2023 year. These awards include maintenance projects, an improvement project, and an access channel dredging project. 

Maintenance Projects. The Company was given several maintenance projects, with the largest award ($15.4 million) being in South Carolina and dredging in the Charlestown Lower Harbor. The second largest ($13.0 million, $14.5 million with options) is in Florida and dredging in the Tampa Harbor Entrance Channel. Four smaller projects were bundled in the announcement, but the projects total $14.8 million in awards and are in New York, North Carolina, and South Carolina….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Newrange Gold (NRGOF) – The Plot Thickens

Posted on by Admin

Thursday, August 25, 2022

Newrange Gold (NRGOF)
The Plot Thickens

Newrange is focused on district-scale exploration for precious metals in the prolific Red Lake District of northwestern Ontario. The past-producing high-grade Argosy Gold Mine is open to depth, while the adjacent North Birch Project offers additional blue-sky potential. Focused on developing shareholder value through exploration and development of key projects, the Company is committed to building sustainable value for all stakeholders. Further information can be found on our website at www.newrangegold.com .

Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Financing closed. Newrange Gold closed a private placement of 10 million units at a price of C$0.03 per unit for gross proceeds of C$300 thousand. Each unit consists of one common share and one share purchase warrant that entitles the holder to purchase one common share at an exercise price of C$0.05 until August 22, 2024. Insiders subscribed for a total of ~1.1 million units. Approximately 20% of the proceeds will fund field logistics at the North Birch and Argosy projects in Ontario, with the remainder to fund due diligence on a contemplated acquisition along with general working capital needs.

Anticipation builds. Newrange is contemplating an acquisition following its decision to terminate its option on the Pamlico project in Nevada. We think management is focused on securing a new flagship project to complement its 100% ownership of the North Birch and Argosy mine projects in the Red Lake area of Ontario, Canada. We think that an acquisition would likely be precious metals focused or polymetallic.…

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Treating Chronic Heavy Drinkers with Hallucinogens – Results are More than Promising

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Image Credit: Cottonbro (Pexels)


Psilocybin-Assisted Psychotherapy vs. Placebo in the Treatment of Adult Patients With Alcohol Use Disorder

“Psilocybin administered in combination with psychotherapy produced robust decreases in the percentage of heavy drinking days compared with those produced by active placebo and psychotherapy.” This is the result of a study designed to see if the ingredient in “magic mushrooms,” coupled with therapy, curbs drinking in adults with alcohol use disorder. The study, published in JAMA Psychiatry, said drinking was curbed for at least eight months, and nearly half the participants receiving psilocybin stopped drinking entirely. 


Introduction

Psilocybin and other classic psychedelics to treat neuropsychiatric conditions have been experiencing a resurgence in study not seen since the 1960s. Alcohol use disorder (AUD) is considered a particularly promising target for treatment with psychedelics. Six clinical trials published between 1966 and 1971 demonstrated that participants with alcohol dependence treated with lysergic acid diethylamide (LSD) showed signs of remission during follow-up nearly twice as often as those not treated. Picking up on this line of research, after more than 40 years, a study published in 2015 demonstrated that moderately high doses of psilocybin (21 to 28 mg/70 kg) were well tolerated by participants with alcohol dependence, and large reductions in drinking were observed over a 32-week follow-up period.

Offering additional proof-of-concept, a multisite randomized clinical trial evaluated the efficacy of psilocybin-assisted psychotherapy for the treatment of AUD. The outcomes of the double-blind trial were reported on August 24 in a peer-reviewed journal for clinicians; highlights of the study appear to confirm earlier studies.

 

Method of Study

Men and women, 93 in all, between the ages of 25 and 65, that were being treated for AUD participated in the multiyear study. Roughly half of the participants took one psilocybin pill, followed by another a month later. The remaining participants served as a control group and were unknowingly administered a placebo (Benadryl).

Prior to the first medication/placebo dose, participants had up to a dozen counseling sessions given by a pair of psychotherapists. The therapists worked to help the participants set objectives to minimize their alcoholic drinks and to help them navigate what could be very emotional psilocybin experiences.

The study was originally designed to randomize up to 180 participants. However, following an indefinite mandatory suspension of recruitment beginning on March 19, 2020, due to the outbreak of COVID-19, enrollment for this trial was halted at 95 randomized participants.


Participants

Participants were recruited from March 12, 2014, to May 13, 2015, at the University of New Mexico and from July 9, 2015, to March 19, 2020, at New York University, using advertisements in local media. The 25 to 65-year-olds had a diagnosis of alcohol dependence determined by the Structured Clinical Interview and had at least four heavy drinking days during the 30 days prior to screening (defined as five or more drinks in a day for a man and four or more drinks in a day for a woman). Excluded were those with major psychiatric and drug use disorders, any hallucinogen use in the past year or more than 25 lifetime uses, medical conditions that contraindicated either of the study medications, use of exclusionary medications, and current treatment for AUD.


Trial Design

Qualifying participants were assessed at screening, baseline (week 0), and weeks 4, 5, 8, 9, 12, 24, and 36. They were randomly assigned to receive either psilocybin or Benadryl (diphenhydramine), administered in two 8-hour sessions at weeks 4 and 8. All participants who completed the double-blind observation period (weeks 5 to 36) and still met safety criteria were offered an open-label psilocybin session at week 38, including four additional psychotherapy sessions and assessment for an additional 18 weeks.

Participants received up to a total of $560 for completing assessments in the course of the trial but were not reimbursed for attending the therapy and medication sessions.

 

Randomization and Blinding

Randomization was stratified by site. A study pharmacist at each site generated the randomization sequence and assigned treatment in order of randomization. All other study staff and investigators, as well as participants, were blind to treatment assignment.


Image: Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder (JAMA Network


Dosage

Study medication was taken orally in a single capsule of unvarying appearance and weight. Psilocybin doses were weight-based to control for participant body weight. Doses for the first session were psilocybin, 25 mg/70 kg, or diphenhydramine, 50 mg. Participants received an increased dose in the second session if there were no dose-limiting adverse events and if they agreed to the increase. The increased dose of psilocybin was 30 mg/70 kg if the participant’s total score on the Pahnke-Richards Mystical Experience Questionnaire (MEQ)42 was 0.6 or greater in the first session (indicating a robust subjective response to the 25 mg/70 kg dose) or 40 mg/70 kg if the MEQ total score in the first session was less than 0.6. The increased dose of diphenhydramine was 100 mg regardless of subjective response.

 

Administration of Study Medication

Psilocybin was administered in the morning; participants were required to stay in the session room with the therapists for at least 8 hours after. During the session, participants were encouraged to lie on a couch wearing eyeshades and headphones, providing a standardized playlist of music. Other medications were available in the session room to treat hypertension, severe anxiety, or psychotic symptoms as specified in the protocol.

Blood pressure and heart rate were measured at 30- to 60-minute intervals during the first 6 hours of each session. After each, participants and therapists were asked to guess which medication had been administered and rate their degree of certainty on a 100-point visual analog scale (0?=?not at all confident; 100?=?extremely confident). This uncovered a flaw in the study as Benadryl was ineffective in maintaining the blind intention after drug administration, so biased expectancies could have influenced results.


Outcome

The primary alcohol consumption outcome was measured as the percentage of heavy drinking days during weeks 5 to 32. Drinking was assessed at weeks 8, 12, 24, and 36 using the timeline follow-back method. One standard drink was defined as 14 g of ethanol. Secondary outcomes included the percentage of drinking days, mean drinks per day, and dichotomous outcomes. Hair or fingernail samples were collected at week 24 and assayed for ethyl glucuronide (EtG) concentration to confirm self-reported abstinence.

There were 204 reported adverse events (119 in the psilocybin group and 85 in the Benadryl group) during the 32 weeks following the first administration of the study medications. Three serious adverse events were reported, all in the Benadryl group. One participant had two psychiatric admissions due to suicidal ideation during binge drinking episodes. Another participant was hospitalized for a Mallory-Weiss tear due to severe vomiting during a binge drinking episode.


Psilocybin in the US

There is a growing cry to take psychedelics medically mainstream. The federal government appears to be moving forward to unwind some strict prohibitions on psychedelic research. In May, the Substance Abuse and Mental Health Services Administration released a letter saying that the agency now agrees that psychedelics hold promise in psychiatric care. It is exploring the creation of a task force to assess how the medicines could be used safely in clinical settings.

In the U.S. nearly 15 million people age 12 or older have AUD, according to the 2019 National Survey on Drug Use and Health.

 

Take Away

Participants suffering from problem drinking were given psilocybin along with psychotherapy. The result of the study medication was a robust and sustained decrease in drinking. These results support further study of psilocybin-assisted treatment for adults with AUD.

A recent NobleCon investor event featured a panel presentation with representatives of related fields discussing both regulatory reform and the results of their treatments and studies. There were also panel presentations from the management of companies providing promising treatments from once taboo sources. Click on links below (Suggested Content) to watch these presentations.

Paul Hoffman

Managing Editor, Channelchek

Suggested Content



PsyBio Therapeutics (PSYBF) NobleCon18 Presentation Replay

Psyched Wellness (PSYCF) NobleCon18 Presentation Replay




Wesana Health (WSNAF) NobleCon18 Presentation Replay

Mental Wellness: Psychedelics? NobleCon18, Panel Replay


Sources

JAMA
Clinical trial Protocol

https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2795625

https://www.wsj.com/articles/psychedelic-compound-in-magic-mushrooms-shows-new-promise-as-alcohol-addiction-treatment-11661354909?mod=Searchresults_pos1&page=1

https://cde.drugabuse.gov/instrument/d89c8e23-16e5-625a-e040-bb89ad43465d

Stay up to date. Follow us:

 

Pangaea Logistics (PANL) – Ship Acquisition Follows Balanced Strategy of Growth and Rewarding Stakeholders

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Thursday, August 25, 2022

Pangaea Logistics (PANL)
Ship Acquisition Follows Balanced Strategy of Growth and Rewarding Stakeholders

Pangaea Logistics Solutions Ltd. (NASDAQ: PANL) provides logistics services to a broad base of industrial customers who require the transportation of a wide variety of dry bulk cargoes, including grains, pig iron, hot briquetted iron, bauxite, alumina, cement clinker, dolomite, and limestone. The Company addresses the transportation needs of its customers with a comprehensive set of services and activities, including cargo loading, cargo discharge, vessel chartering, and voyage planning. Learn more at www.pangaeals.com.

Michael Heim, CFA, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Ship acquisition announced. Pangaea announced the acquisition of a 2010-built vessel for US$17.1 million. Management had indicated it was in final negotiations for a ship purchase during its August 18th call to discuss second quarter financial results so the announcement was not a surprise. Pangaea has operated the ship for over a year on a chartered-in basis and had been approached by the owner. The ship will be delivered in September or October. Owned ships typically command higher margin contracts than chartered-in ships so the acquisition should have a positive impact on financial results going forward.

Acquisition follows management’s balanced strategy of growth and rewarding stakeholders. The Board of Directors has raised the dividend twice in the last twelve months although it opted to hold dividends constant in the most recent quarter. It has also paid down debt and capital leases in recent quarters. The ship acquisition will help grow Pangaea’s asset base. Pangaea’s cash position was $102.2 million (up from $40.6 million at this time last year). We believe the company will pay for the ship, which will be renamed Bulk Sachuest, with cash on hand….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Ayala Pharmaceuticals Selected to Present Efficacy and Tolerability Data on AL102 in Desmoid Tumors at the European Society for Medical Oncology ESMO 2022 Congress

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Ayala Pharmaceuticals Selected to Present Efficacy and Tolerability Data on AL102 in Desmoid Tumors at the European Society for Medical Oncology (ESMO) 2022 Congress

Research, News, and Market Data on Ayala Pharmaceuticals

Oral presentation will feature results from Part A of the Phase
2/3 RINGSIDE clinical study

REHOVOT, Israel and WILMINGTON, Del., Aug. 24, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced that data on the efficacy and tolerability of investigational new drug AL102 from Part A of the Phase 2/3 RINGSIDE study will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress, to take place September 8-13, 2022 in Paris, France.

The presentation details follow:

 

 

Abstract Title:

Initial Results of Phase 2/3 Trial of AL102
for Treatment of Desmoid Tumors (DT)

Presentation
Number:

1488MO

Session Type:

Mini Oral Session

Session
Title:

Sarcoma

Session Date and Time:

Monday, September 12, 2022, at 2:45 pm CEST / 8:45 am EDT

About the RINGSIDE study
The RINGSIDE pivotal Phase 2/3 study is a randomized multi-center trial. Part A of the study is evaluating the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in adult patients with desmoid tumors. It enrolled 42 patients and is evaluating 3 doses of AL102. Patients who participated in Part A will be eligible to enroll into an open-label extension study at the selected Part B dose, and long-term efficacy and safety will be monitored. Part B of the study will be double-blind, placebo-controlled, and will start immediately after dose selection from part A, enrolling up to 156 adult and adolescent patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.

For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors
Desmoid tumors also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com. 

Contacts

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602

jallaire@lifesciadvisors.com 

Ayala Pharmaceuticals:
+1-857-444-0553

info@ayalapharma.com 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; our existing collaboration with Novartis is, and any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2021 and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 


Release – BioSig Places Second PURE EP™ System For Evaluation at Cleveland Clinic a Leading Medical Center of Excellence

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BioSig Places Second PURE EP™ System For Evaluation at Cleveland Clinic a Leading Medical Center of Excellence

News and Market Data on BioSig Technologies

August 24, 2022

Westport, CT, Aug. 24, 2022 (GLOBE NEWSWIRE) —

  • Leading Medical Center
    of Excellence adds second PURE EP™ System for evaluation, broadening
    physician access to the Company’s signal processing technology
  • PURE EP™ is now being
    evaluated at both Main and Fairview campuses of Cleveland Clinic’s Heart,
    Vascular & Thoracic Institute 

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced that it has installed a second evaluation system at the Cleveland Clinic. The additional installation will support the medical center’s clinical evaluation of the PURE EP™ System and expand physician access to the Company’s signal processing technology. 

“I am pleased to see the growing interest and demand for our technology at The Cleveland Clinic. The additional unit will enable more physicians the opportunity to experience the superior signal quality of the PURE EP™ System on a broad range of cases.” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.

Consistent with its stated national commercial strategy, the Company’s customer-centered approach aims to maximize the clinical value and deployment of the PURE EP™ System which has gained interest in several electrophysiology labs in the Midwest. The Company recently expanded its clinical footprint in Illinois with an additional evaluation agreement at a leading medical center in Springfield, the state capital.

Looking ahead, BioSig will serve as a partner at the upcoming Cleveland Clinic Global EP Summit 2022, due to take place this coming September. This annual forum convenes over 40 global experts and highlights the latest practice insights across the spectrum of electrophysiology care.

 

About
Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. As a leader in arrhythmia treatment and diagnosis, Cleveland Clinic medical centers include state-of-the-art electrophysiology laboratories, world-class physicians and researchers, and the latest cutting-edge technologies and protocols deployed for the treatment of heart abnormalities. To learn more, visit clevelandclinic.org.

 

About
BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System, is a novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP™ was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights. The Company is in a national commercial launch of the PURE EP™ System. The technology is in regular use in some of the country’s leading centers of excellence, including Mayo Clinic, and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.

Clinical data acquired by the PURE EP™ System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(T.M.) signals over conventional sources.

 

Forward-looking
Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.


Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 

Primary Logo

Source: BioSig Technologies, Inc.

Released
August 24, 2022


Crypto’s Ledger Technology is Keeping Track of Stock Ownership

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Image Credit: Marco Verch (Flickr)


Why Blockchain May Now be Keeping Tabs on that Stock You Just Bought

If you’re invested in stocks that clear or settle in the U.S., it’s extremely likely the Depository Trust and Clearing Corp. (DTCC) has been entrusted with keeping your assets safe. So when the DTCC announced progress on Project Ion this week, a move that introduces distributed ledger blockchain technology into trade clearing and tracking, the success or failure will impact you and perhaps the speed and accuracy of change in recorded ownership of shares. It also would be seen as a nod by a quasi-government entity to recording asset ownership using crypto.

 

About Project Ion

The Project Ion platform was developed as an alternative test settlement platform that is implemented with distributed ledger technology (DLT). It is now live, running parallel with standard DTCC settlements for DTCC members. Project Ion is currently processing an average of over 100,000 equity transactions per day and almost 160,000 transactions on peak days. While in parallel production, DTCC standard settlement systems remain the authoritative record.

The project was launched in 2020 and is testing on a small fraction of the billions of shares that change hands each day.

“Digitized assets and emerging technology like DLT are shaping and evolving the financial services landscape, and we remain committed to advancing innovative solutions that capitalize on opportunities, deliver new value and drive the industry forward,” said Murray Pozmanter, managing director and president of DTCC Clearing Agency Services.


Ramifications of Crypto Settlement

As a member of the Federal Reserve and counterparty to the major U.S. exchanges and markets, DTCC clears and settles virtually all broker-to-broker securities transactions, including registered stocks, listed corporate, muni bonds, and UIT trades in the country; the transaction volume is enormous.

The DTCC, a subsidiary of the Depository Trust Company (DTC) has always been out front adopting new technology in order to help improve speed and accuracy of trade settlements. Without the DTC we’d all still be taking physical delivery of stock certificates.

It is now looking to implement crypto-style tracking and is running live testing of a private blockchain to see whether it’s sufficient to clear and settle transactions in the $40 trillion equities market. This could also help move toward faster settlements and fewer securities lending issues.

Not to be overlooked this is a huge milestone for the blockchain technology. Traditional finance’s most trusted and relied upon center is embracing the ledger technology, the same technology that forms the foundation of bitcoin (BTC), Ethereum (ETH) and NFTs.   

Settling stock trades in the U.S. currently takes two days (T+2), which, when compared to the speed of cryptocurrency settlement, is like comparing travel by plane to travel on horseback. High-speed trading, done in fractions of a second, but settling in T+2 is clumsy and needs to improve. Last year brokers were forced to restrict meme stocks from trading because of a $3 billion collateral request from DTCC, which stockpiles money as a safeguard in case something bad happens during the two days while it’s processing a trade. Robinhood and others became involved in lawsuits as the restrictions had costs for their clients.

The U.S. Securities and Exchange Commission (SEC) has proposed speeding up stock settlement times to something called T+0, or same day as executed. Last year, Robinhood (HOOD) CEO Vlad Tenev said that T+0 would’ve prevented volatile markets like those seen with meme-trader favorites GameStop (GME) and AMC (AMC).

Project Ion is private and permissioned and has been developed with large financial firms, including BNY Mellon (BK), Charles Schwab (SCHW), Barclays (BCS), Citadel Securities, Citigroup (C) and Credit Suisse (CS). DTCC partnered with software provider R3 to launch Project Ion using R3’s Corda distributed ledger technology (DLT) software.

 

Take Away

Without DTC, which is the parent of DTCC, all public market trading on Wall Street literally stops. DTC is registered as a clearing agency with the Securities and Exchange Commission, but they are the clearing partner for all the major clearing houses. Organized as a limited purpose trust company under the New York Banking law and a member of the Federal Reserve System, they have quasi-government status. Its foray into using distributed ledger technology to clear trades shows acceptance of blockchain at the highest levels in finance and may one day make T+0 possible.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://www.dtcc.com/news/2022/august/22/project-ion

https://www.cftc.gov/sites/default/files/stellent/groups/public/@otherif/documents/ifdocs/dtccjurisdictionnar.pdf

https://www.sec.gov/rules/concept/s71502/ddirks1.htm

https://www.dtcc.com/clearing-services#:~:text=As%20the%20central%20counterparty%20for,handle%20today’s%20enormous%20trading%20volumes.


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