Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care provides the following update in regard to an unsolicited approach from a possible strategic acquiror, launch of a Formal Sale Process, and its advanced financing activities.
Monday, March 4, 2024
Quoin to Recruit Teen Subjects into Both Ongoing Netherton Syndrome Studies
Clearance to include teen patients in both the company’s open label and placebo controlled studies expected to significantly expand the number of eligible subjects, potentially expedite recruitment and lead to a more robust data set
This important development represents the first ever inclusion of non-adult subjects in Netherton Syndrome clinical studies conducted under an open Investigational New Drug Application
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a specialty pharmaceutical company focused on rare and orphan diseases, today announced clearance from the U.S. Food and Drug Administration (FDA) to recruit teen subjects aged 14 years and older into its two ongoing clinical trials for QRX003, which is being developed as a potential treatment for Netherton Syndrome (NS). Both trials are being conducted under Quoin’s open Investigational New Drug Application (IND) for QRX003.
Dr. Michael Myers, Chief Executive Officer of Quoin, said, “We are very pleased to announce this exciting development, not just for Quoin’s clinical program, but for the Netherton community as a whole. We are frequently petitioned by parents and caregivers that teen subjects be allowed to participate in our clinical studies, given the severity of the disease and the absolute dearth of viable treatment options. Today, it is our privilege to announce that we have FDA clearance to do just that.
“This FDA clearance represents the very first time that non-adult Netherton subjects will be tested in clinical studies conducted under an open-IND and, as such, represents a very significant and important step forward for members of this community. Significantly, teens who are currently receiving off-label systemic therapy will be eligible to participate in our open-label study, while those who are not receiving such therapy may be recruited into the placebo controlled blinded study. This important feature not only widens the pool of eligible subjects but also eliminates the need for parents or caregivers to make difficult decisions about treatments these patients and loved ones are receiving. The inclusion of this patient population in our studies will be, we believe, a critical component of the development of a robust data set that could result in regulatory approval with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments.
Sunday, March 3, 2024
China Buys Hefty Amount of Foreign Grain as Global Prices Slump
China snapped up more than 20 cargoes of feed grain on the international market in the past two weeks as the world’s biggest importer took advantage of a decline in prices to the lowest level in more than three years.
The country secured shipments of corn, sorghum and barley from suppliers including Ukraine and the US, according to people familiar with the transactions. The purchases amount to over 1.2 million tons of grain on the basis of each cargo being 60,000 tons.
US Supreme Court Ruling On Trump Ballot-Ban Case Could Come On March 4
by Jack Phillips via The Epoch Times,
The U.S. Supreme Court could issue a ruling as early as March 4 regarding a case that seeks to bar former President Donald Trump from appearing on primary and general election ballots for the 2024 presidential election.
The Supreme Court, in an unusual Sunday update to its schedule, didn’t specify what ruling it would issue. However, the justices on Feb. 8 heard arguments in the former president’s appeal of a ruling in Colorado and are due to issue their own decision.
The March 3 announcement said the opinion would be posted online at 10 a.m. Washington time. “The court will not take the bench,” it only said on its website.
Late last year, the Colorado Supreme Court ruled that President Trump is disqualified from appearing on ballots in Colorado, citing an interpretation of the U.S. Constitution’s 14th Amendment provision that stipulates that candidates who engaged in an “insurrection or rebellion” against the United States should be prevented from holding office. Maine’s Democratic secretary of state made a similar decision days later, and a judge in Illinois recently issued a similar ruling to prevent his appearance on ballots.
The amendment was drafted more than 150 years ago, after the Civil War, and the court was the first to invoke it. However, that ruling and the two others are on hold pending the Supreme Court decision.
The former president appealed the Colorado court ruling to the Supreme Court, which took up the matter quickly. Oral arguments in the case were heard last month.
Notably, the Supreme Court has until now never ruled on the provision, Section 3 of the 14th Amendment. The court indicated this weekend that at least one case would be decided on March 4, although it didn’t indicate which one.
Except for when the end of the term nears in late June, the court almost always issues decisions on days when the justices are scheduled to take the bench. But the next scheduled court day is March 15. And apart from during the coronavirus pandemic, when the court was closed, the justices almost always read summaries of their opinions in the courtroom.
If the resolution of the case comes on March 4, a day before Super Tuesday primary contests in 16 states, it would remove uncertainty about whether votes for President Trump, the leading Republican candidate for president, will ultimately count.
Colorado and Maine are two of the states that will hold its GOP primary during the March 5 Super Tuesday contest.
Lawyers for the former president asked the nine justices to reverse the Colorado court decision because only Congress can make a determination as who can become president.
The court’s decision is also “the first time in the history of the United States that the judiciary has prevented voters from casting ballots for the leading major-party presidential candidate,” his lawyers said, concluding that it “is not and cannot be correct.”
After the ruling, President Trump wrote on social media that he is “not an insurrectionist,” adding that President Joe Biden is one. He also noted that he told supporters to protest “peacefully and patriotically” during a rally on Jan. 6, 2021, before protesters and rioters entered the U.S. Capitol during the certification of electoral votes for the 2020 election, which forms the basis of the “insurrection” accusations against him.
Justices for the Colorado Supreme Court had argued that they believed President Trump engaged in an insurrection because of his activity before and on Jan. 6, 2021, during the breach of the U.S. Capitol building. The former president, however, was never charged or convicted of insurrection. He was charged by a federal special counsel in connection with the 2020 election, but not for insurrection, rebellion, or related charges.
“President Trump asks us to hold that Section Three disqualifies every oath-breaking insurrectionist except the most powerful one and that it bars oath-breakers from virtually every office, both state and federal, except the highest one in the land,” the majority for the Colorado Supreme Court wrote in its 4–3 ruling.
“Both results are inconsistent with the plain language and history of Section Three.”
Oral Arguments
During oral arguments in front of the justices in early February, at least six of the justices, including Chief Justice John Roberts, who was nominated by President George W. Bush, appeared to be at least skeptical of some of the claims made by the lawyer representing several Colorado voters who brought the lawsuit against the Republican front-runner.
“It’ll come down to just a handful of states that are going to decide the presidential election,” Chief Justice Roberts said, referring to the potential effect of the Colorado court’s ruling.
“That’s a pretty daunting consequence.”
Justice Clarence Thomas asked the lawyer, Jason Murray, why there weren’t many examples of individual states’ disqualifying candidates under the 14th Amendment after the Civil War.
“There were a plethora of confederates still around, there were any number of people who would continue to either run for state offices or national offices, so it would seem—that would suggest there would at least be a few examples of national candidates being disqualified,” Justice Thomas, a Bush appointee, said.
Justice Elena Kagan, considered a member of the court’s liberal wing, asked the attorney why one state would have power to determine which candidates should be on the ballot for a nationwide election.
“Why should a single state have the ability to make this determination not only for their own citizens but also for the nation?” she asked the attorney, adding the move would be “quite extraordinary.”
https://www.zerohedge.com/political/us-supreme-court-ruling-trump-ballotban-case-could-come-march-4
Super Tuesday to test resurgent crypto industry's political might
Crypto is back! And it's not just in the markets.
The burgeoning cryptocurrency industry is jumping into the 2024 U.S. election, spending millions of dollars in Super Tuesday primary contests in California, Alabama and Texas to boost crypto-friendly candidates and defeat those pushing for more regulation.
How these candidates perform on Tuesday, when dozens of races across America are whittled down to two contestants, will indicate how much influence the increasingly wealthy crypto executives may wield in November.
Brand new industry super PACs, or independent fundraising groups, Fairshake, Protect Progress and Defend American Jobs, backed by funds from Coinbase and the Winklevoss twins have spent at least $13 million in Tuesday's primary races, according to a Reuters analysis of data from OpenSecrets, a research group that tracks money in U.S. politics and its influence on elections and policy.
And that's just the beginning, officials say.
"The crypto community is playing politics to win," said Fairshake spokesperson Josh Vlasto. "We will have influence and impact in races behind candidates who align with our agenda and our vision."
In total, the three super PACs have raised nearly $102 million from January 2023 to January 2024, data from the Federal Election Commission showed.
The cryptocurrency industry has surged in recent months, and Bitcoin hit a new high last week, after the collapse of several big players in 2022 crushed prices and prompted a regulatory crackdown.
The industry, including its employees and political action committees, has so far contributed about $59.2 million toward the 2024 election cycle, up from $26.8 million in the 2022 midterm cycle and $1.6 million in the 2020 cycle, OpenSecrets data showed.
California progressive Democrat Katie Porter, who is running for Senate, is a key target. Fairshake has spent over $10 million to try to convince voters not to back Porter, including launching a statewide TV and digital media buy.
Porter joined U.S. Senator Elizabeth Warren in 2022, seeking information from Texas' electric grid operator on cryptomining operations in the state and how the power the industry uses affects climate change and the energy grid.
"This shady super PAC is spending more than $10 million to kick Katie out of Washington because they know she will stand up for Californians and take on powerful special interests like them in the Senate," said Porter's campaign spokesperson Lindsay Reilly.
Protect Progress has also spent about $1.7 million to back Shomari Figures, a Democrat and former deputy chief of staff to U.S. attorney general Merrick Garland running in Alabama's 2nd congressional district race. A Democrat is expected to win the hotly-contested race, which was sparked after a federal court ordered Alabama to draw a new Congressional map.
Figures, if elected, has pledged to "embrace the new landscape around digital assets, like Cryptocurrency, to stimulate innovation and technological advancement," his website says.
In Texas, Protect Progress has put about $962,000 in support of Representative Julie Johnson, a Democrat running in the state's 32nd congressional district race.
Meanwhile, Defend American Jobs has allocated over $1 million to back Representative John Bradford III and Representative Tim Moore, both Republicans in North Carolina, OpenSecrets data showed. Moore is the speaker of the state's House.
Democrats are favored to take control of the House of Representatives in the 2024 election, perhaps by a slim margin, meaning individual Congress members could play pivotal roles in passing legislation.
"You have candidates in all of those races who have demonstrated not only an openness to learning and thinking more about digital assets, but actually calling on Congress and on policymakers to take action there," said Kara Calvert, head of U.S. policy at Coinbase.
Coinbase, an online platform for buying and selling crypto, is also behind a non-profit group called the Stand With Crypto Alliance that now counts 315,000 members, which aims to organize voters who own crypto and influence public opinion.
The industry's interest in the 2024 election comes on the heels of one of the biggest financial frauds on record. FTX founder Sam Bankman-Fried was found guilty last year of stealing from customers. Prosecutors allege he used those funds to donate more than $100 million to U.S. political campaigns.
Federal election disclosures show he gave roughly $40 million to mostly Democratic-aligned groups and campaigns.
An indictment also accused Bankman-Fried of directing two FTX executives to evade contribution limits by donating to Democrats and Republicans to the tune of $9.7 million to Democratic candidates and causes, and more than $24 million to Republican candidates and causes in 2022.
At least some have returned the money after.
"The experience of FTX/Alameda should be a cautionary tale" for any campaign, said Ciara Torres-Spelliscy, a professor of law at Stetson University College of Law. Alameda Research was Bankman-Fried's crypto-focused hedge fund.
"The FTX/Alameda funds that went into politics are subject to two different attempts to claw back the money: One claw back from the bankruptcy estate of FTX and another claw back from federal prosecutors who consider the money fruits of a crime."
GH Research Results And Business Updates
Nasdaq-listed, GH Research
is a clinical-stage biopharma business developing novel 5-MeO-DMT therapies as transformative treatment of psychiatric and neurological disorders.
Its reported yearly financial results show:
- Cash position of $ 222.7 million by December 31, 2023, an 11.5% decrease as compared to that held by December 31, 2022.
- Yearly R&D expenses totaled $29.8 million, a 45% increase as compared to the $20.5 million spent in 2022.
- Yearly G&A expenses totaled $11.4 million, a 12.8% increase as compared to the $10.1 million spent in 2022.
- Yearly net loss of $35.6 million (or $0.68 loss per share), a 58% rise from the 2022 net loss ($22.5 million, or $0.43 loss per share.)
Additional financial assets held during the fiscal year 2023 include money market funds and marketable securities (held both in 2022 and 2023) involving investment-grade bonds.
The GH Research team stated its existing cash, cash equivalents, additional financial assets and marketable securities "will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2026."
Clinical Pipeline & IP Portfolio In Development
GH Research portfolio focuses on three mebufotenin (or 5-MeO-DMT) assets: lead product candidate GH001, a proprietary inhalation formulation in Phase 2 clinical trials; GH002, a proprietary intravenous formulation in Phase 1 clinical-stage; and GH003, a proprietary intranasal formulation undergoing preclinical development.
GH001 has passed two Phase 1 clinical trials on healthy volunteers, as well as a Phase 1/2 clinical trial in patients with Treatment-Resistant Depression (TRD) with strong positive outcomes: 87.5% of TRD patients were brought into an ultra-rapid remission with a single-day dosing regimen.
The company's lead compound is now being assessed in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial in 80 patients with TRD, and in two Phase 2a trials: one in patients with bipolar II disorder and a current depressive episode (BDII,) and another in patients with postpartum depression (PPD.)
The Phase 2b trial is recruiting participants in about 20 European sites. Its double-blind phase is expected to be completed in Q3 2024, delivering topline data in Q3 or Q4, 2024. In the trial, GH001 is administered via an externally-sourced inhalation device, on a single initial-dosing day without additional required psychotherapy or psychological support visits before or after dosing.
GH001's assessment in patients with PPD and BDII is also at the recruiting stage. The PPD trial is now expecting completion and availability of topline data in Q3 2024, while the BDII trial's updated timeline is still to be determined.
Meanwhile, the company's Investigational New Drug Application (IND) for GH001 administered via its proprietary aerosol device was placed on clinical hold by the FDA.
The federal agency requested that GH Research provide: an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, additional device design verification information, and updates to its investigator brochure to resolve the hold.
The company reported it is working to respond to the FDA's requests, initiating the nonclinical studies and preparing the device design verification information.
"In addition, we have recently requested a meeting with the FDA to discuss certain aspects of the FDA's feedback," the company wrote in a press release. "We intend to provide an update regarding the IND response submission and the planned Phase 1 healthy volunteer clinical pharmacology trial in Q2 2024. In parallel, to mitigate a potential delay to the GH001 program, we are also progressing preparations to potentially conduct the Phase 1 healthy volunteer clinical pharmacology trial in Europe."
As for intellectual property, the European Patent Office (EPO)'s January grant enables the company to claim mebufotenin (5-MeO-DMT) or "a pharmaceutically acceptable salt thereof" for use in treating patients diagnosed with Major Depressive Disorder (MDD) and treatment-resistant forms of MDD, including TRD.
The patent is now effective, with an expiry date of no earlier than 2040, and is expected to cover all mebufotenin and mebufotenin salt products marketed to treat MDD and TRD, including but not limited to products administered through pulmonary inhalation, intravenous and intranasal routes.
More recently, the EPO granted the company two more patents. One, covering "crystalline hydrobromide salt" of mebufotenin (effective date March 13, 2024 and expiry date no earlier than 2043;) and another directed to "a specific method of purifying mebufotenin" (effective date March 13, 2024 and expiry date no earlier than 2040.)
Russian Oil No Longer Sells At A Discount As Nobody Complies With Western Sanctions
Remember when, in the immediate aftermath of the Ukraine war, Russian oil immediately traded down to a discount of as much as 30% below spot Brent as the entire western world suddenly found itself locked out of access to the most valuable Russian export (which also meant that China and India were the only natural buyers left) and the price of Russian oil had to reflect the explicit plunge in demand?
Well, that's no longer the case because in the two years since the start of the Ukraine conflict, it became apparent that Western sanctions were merely a theatrical publicity stunt as the alternative - strict enforcement - would have sent oil prices soaring and that would be unacceptable to a Biden administration terrified of losing the November elections if and when oil and gasoline prices surges.
And as fear of enforcement became a non-issue over time, so did the discount of Russian oil to Brent, which brings us to today, and Goldman's "chart of the week" which illustrates the collapse in the discount on Russian crude oil close to zero relative to Brent, according to the bank's estimates using the most recent customs data for December.
According to Goldman, which estimates the effective price of Russian crude paid by its trade partners using detailed customs data on import volumes and import payments for Russia crude, this drop in the price discount was primarily driven by the countries outside of the G7 coalition.
However, the discount has also narrowed for most of the buyers as Russian fleets were becoming more capable of operating under the G7 price cap.
The US Treasury’s recent decision to target Sovcomflot, Russia’s state-owned shipping company and fleet operator, comes against the backdrop of the drop in the effective discount late last year and the twin goals of US policymakers to “limiting Kremlin profits while promoting stable energy markets.”
It is also an admission that western attempts to prevent Putin from generating oil export revenues - critical in keeping the Russian war machine going - were either a failure, or merely a theatrical, virtue signaling sleight-of-hand from the beginning. And while the former is bad, the latter is far more disturbing as it suggests that the west has been willingly enabling Putin to sell oil and fund the war in Ukraine, the same war with Western nations are so vocally against.
Almost as if both Russia and the West are aligned in their (shared) goal of keeping the war in Ukraine going to its inevitable and dire, for Zelenskyy, conclusion; it also almost makes one wonder if the destruction of Ukraine - at the hands of Russia with the implicit enabling by the West - was a pre-planned exercise all along.
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