Contineum Therapeutics, a Phase 1 biotech developing small molecule therapies for IPF and multiple sclerosis, announced terms for its IPO on Monday.
The San Diego, CA-based company plans to raise $150 million by offering 8.8 million shares at a price range of $16 to $18. At the midpoint of the proposed range, Contineum Therapeutics would command a fully diluted market value of $490 million.
Contineum Therapeutics is focused on discovering and developing novel, oral small molecule therapies for the treatment of neuroscience, inflammation, and immunology (NI&I) indications with high unmet need. Its wholly-owned lead asset, PIPE-791, is a novel, brain penetrant, small molecule inhibitor in development for idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (Progressive MS). The company has completed a Phase 1 trial of PIPE-791 in healthy volunteers in both indications, and it plans to submit a Clinical Trial Authorization to the Medicines and Healthcare products Regulatory Agency to commence a Phase 1b open-label trial in 2024. Contineum is collaborating with Johnson & Johnson on its second candidate, PIPE-307, which has entered a Phase 2 trial in relapse remitting MS.
Contineum Therapeutics was founded in 2009 and booked $50 million in license revenue for the 12 months ended December 31, 2023. It plans to list on the Nasdaq under the symbol CTNM. Goldman Sachs, Morgan Stanley, Stifel, and RBC Capital Markets are the joint bookrunners on the deal. It is expected to price during the week of April 1, 2024.
Thursday, April 4, 2024
Neuro and inflammation biotech Contineum Therapeutics sets terms for $150 million IPO
Post-acute healthcare provider PACS Group sets terms for $400 million IPO
PACS Group, a post-acute care provider with more than 200 nursing facilities across the US, announced terms for its IPO on Monday.
The Farmington, UT-based company plans to raise $400 million by offering 19.1 million shares at a price range of $20 to $22. At the midpoint of the proposed range, PACS Group would command a fully diluted market value of $3.2 billion.
PACS Group is a post-acute healthcare company primarily focused on delivering skilled nursing care through a portfolio of independently operated facilities. The company states that it is one of the largest skilled nursing providers in the US by number of facilities, with 208 post-acute care facilities across nine states serving over 20,000 patients daily. As of December 31, 2023, it leased 165 facilities, directly owned the real estate at 29 facilities, and owned partial interests in an additional 14 facilities through joint ventures managed by third parties. PACS also provides senior care, assisted living, and independent living options in some of its communities.
PACS Group was founded in 2013 and booked $3.1 billion in revenue for the 12 months ended December 31, 2023. It plans to list on the NYSE under the symbol PACS. Citi, J.P. Morgan, Truist Securities, RBC Capital Markets, and Goldman Sachs are the joint bookrunners on the deal. It is expected to price during the week of April 8, 2024.
Wednesday, April 3, 2024
'FDA clears AI that detects heart failure using a stethoscope'
The FDA has cleared an artificial intelligence algorithm that can detect signs of heart failure in seconds using a digital stethoscope during a standard physical exam.
The algorithm was developed by digital stethoscope maker Eko Health in collaboration with the Mayo Clinic. It looks for low ejection fraction (EF), a reduction in outflow of blood from the heart to the aorta, which is present in approximately 50% of heart failure cases.
If LVEF is 40% or less a patient is considered to have heart failure with reduced ejection fraction (HFrEF), sometimes known as systolic heart failure, which generally has to be diagnosed in a hospital setting.
The Low EF AI means that some cases of heart failure could be spotted in primary care, speeding up referral to specialist cardiac care, even if patients don’t have symptoms. Often, current detection methods like electrocardiography aren’t available in primary care as they are costly, require specialist training, and are time-intensive.
“The ability to identify a hidden, potentially life-threatening heart condition using a tool that primary care and subspecialist clinicians are familiar with – the stethoscope – can help us prevent hospitalisations and adverse events,” said Dr Paul Friedman, chair of the department of cardiovascular medicine at the Mayo Clinic, which is an investor in Eko Health.
“Importantly, since a stethoscope is small and portable, this technology can be used in urban and remote locations, and hopefully help address care in underserved areas,” he added.
At the moment, around 80% of heart failure patients are only diagnosed after an emergency hospital admission.
Eko sells a range of digital stethoscopes and already has two FDA-approved AI algorithms for other cardiac features, one for atrial fibrillation (AF) and another for structural murmurs associated with valvular heart disease, which are sold under its Sensora platform.
The Low EF AI was trained on a proprietary dataset of over 100,000 ECGs and echocardiogram pairs from unique patients and was clinically validated in a multi-site, prospective clinical study involving almost 3,500 subjects. It was found to detect EF below 40%, with a sensitivity of around 75% and 77.5% specificity.
A second, independent study of the algorithm conducted by clinicians at Imperial College London in the UK, published in The Lancet Digital Health, showed a sensitivity of 85% and 69.5% specificity.
“The stethoscope, the most recognisable symbol of healthcare, touches the lives of an estimated 1 billion people around the globe every year,” said Connor Landgraf, co-founder and chief executive of Eko Health.
“We’ve transformed the icon of medicine into an AI-powered heart failure early detection tool that can help improve access to care for millions of patients, at a fraction of the time and cost of echocardiography,” he added.
https://pharmaphorum.com/news/fda-clears-ai-detects-heart-failure-using-stethoscope
4 More Christians Found Guilty Over Prayer Gathering At Nashville Abortion Clinic
by Beth Brelje via The Epoch Times (emphasis ours),
It is likely that the Department of Justice (DOJ) will be throwing an elderly survivor of a communist concentration camp in federal prison for sitting in a wheelchair in the hallway of an abortion business and singing church hymns.
A bench trial at the Fred Thompson Federal Courthouse in Nashville this past week lasted just one day.
By the end of it on April 2, four Christians were convicted of a misdemeanor FACE Law violation. The Freedom of Access to Clinic Entrances (FACE) law prohibits anyone from obstructing, intimidating, or interfering with a woman seeking an abortion.
They had been charged after singing hymns, praying, and persuading women not to abort their babies on March 5, 2021, at the now-defunct Carafem Health Center in Mount Juliet, Tennessee. The DOJ characterized the action as an illegal “blockade.”
The abortion business closed after a change in Tennessee law, prohibiting abortion in most cases. It means the defendants are guilty of trying to stop what is now effectively outlawed in that state.
The four found guilty are Eva Zastrow, 25, of Michigan; James Zastrow, 27, of Missouri; Paul Place, 26, of Tennessee, and Eva Edl, 89, of South Carolina, who was in a wheelchair on the day of the incident.
Each faces up to a year in prison. They remain free until their July sentencing. But Eva Zastrow and Eva Edl have multiple FACE charges. They will go to a Michigan court in August, where each could get up to an additional 11 years in prison on a more aggressive FACE charge.
In January, six other defendants were found guilty of FACE and felony conspiracy (for social media posts showing what they were doing) for the same Tennessee incident. Each of the six could get up to 11 years in prison at their July sentencing. More people are headed to trial for the same action.
After the Supreme Court overturned Roe v. Wade, President Biden formed the Reproductive Rights Task Force, a DOJ-led group that has increased enforcement of the FACE Law.
Victim of Communism
Ms. Edl has been a long-time, peaceful activist at abortion clinics, motivated by her traumatic childhood in communist Yugoslavia. She was removed from her home with her family. They were allowed to keep only a dish and the clothing they wore.
She recalls being stuffed into a cattle car and shipped to a camp where she nearly starved to death, while she watched the people around her die. As a child, she watched the dead being put on wagons and then be buried in mass graves.
“We were considered to be non-human, with just permission given for torturing and killing us by the government,” Edl told an interviewer with WJBF television in 2018.
Our government’s legalizing abortion does not make it right or good, Edl told The Epoch Times in a 2023 interview.
“If it is right for the American government to legalize the killing of innocent human beings inside the womb, preborn babies, then why do we condemn the Nazis who also legalized the extermination of born people—Jews, Gypsies, and others—all unwanted individuals,” Edl said.
“If it is a good thing to kill human beings just as long as the government says so, then we have no right to condemn anybody else. But we all know deep down that these things are evil.”
“Nobody’s life is ultimately safe in a nation ruled by someone who does not respect all human life, from conception to natural death,“she continued. ”It will just depend on who is in power, and whose whim will dictate who is permitted to live, and who is going to be exterminated.”
She called compared abortion businesses to death camps.
“When I was on the cattle car with all my people, and we were shipped to the death camp to be exterminated, the people around us were not in agreement with what the government did. But they were intimidated,” Edl said.
“We have to overcome that fear and do what is right anyhow. … I wished in those days that somebody would have cared enough to go stand on those railroad tracks and say, ‘You cannot take these babies and children unless you go over our dead bodies.’
“If more and more would just lay down their lives and be willing to at least go to jail to protect these babies, we would have more success. But then, who knows what the Lord will do. Maybe he will honor even the sacrifice of the few. I’m always hopeful.”
Biden slammed by Dems, GOP on response to Israeli airstrike that killed 7 aid workers
President Biden has received criticism from Democrats and Republicans this week over his response to an Israeli airstrike that killed seven World Central Kitchen aid workers in Gaza on Monday.
On Tuesday, Biden, 81, said he was “outraged and heartbroken” over the deaths of the aid workers delivering food to Gaza’s population, but didn’t signal any change in approach to his administration’s backing of Israel in its war against Hamas.
The president, in his public statement, pinned the blame squarely on Israel, demanding an investigation that “must bring accountability” and accusing the Jewish state of not having “done enough to protect aid workers” in the Palestinian territory.
Privately, Politico reports, Biden is “enraged” over the airstrike and was “angry” when he was notified that the Israel Defense Forces mistakenly targeted members of celebrity chef Jose Andres’ humanitarian group.
Jon Favreau, a one time speechwriter for former President Barack Obama and the host of “Pod Save America,” slammed Biden over the report, arguing that private expressions of rage are not enough in the aftermath of Monday’s tragedy.
“The President doesn’t get credit for being ‘privately enraged’ when he still refuses to use leverage to stop the IDF from killing and starving innocent people,” Favreau wrote on X.
“These stories only make him look weak,” he added.
Democratic Michigan state Rep. Abraham Aiyash argued that “Deeds are more important than dialogue” in a tweet aimed at Biden.
“The President is prioritizing Netanyahu’s Israel over the preservation of innocent life and basic human decency – and risks unraveling American democracy because of it,” he added.
Meanwhile, some Republicans ripped the president for aiming his ire at Israel rather than Hamas.
“How about Biden being outraged over the American and Israeli hostages being brutalized by the Hamas savages and remembering that Hamas is the cause of all of this tragedy,” Rep. Derrick Van Orden (R-Wis.) fumed on X.
“Biden has abandoned Israel,” he added.
Rep. Mike Waltz (R-Fla.) noted that the Biden administration mistakenly targeted aid worker Zemari Ahmadi, killing him and members of his family in a drone strike as the US withdrew from Afghanistan in August 2021.
“REMINDER: The Biden Administration carried out a drone strike on an aid worker and his family during the disastrous Afghanistan withdrawal,” Waltz tweeted.
“There was no accountability for that action.”
“Biden might want to hold off on the righteous indignation and criticism,” he added.
At least 196 humanitarian workers have been killed in Gaza since the outbreak of the war, according to the United Nations.
France Criminalizes Opposition to mRNA Injections
France enacted a controversial new law in February that critics say could be used against anyone opposing injections with mRNA vaccines or other treatments recommended by the state and based upon current medical knowledge.
The law aims to combat religious violence, but under one section, criticism of therapeutic treatments when mandatory or recommended by the government could result in up to three years of imprisonment or a fine of 45,000 euros. The provision, which was quickly dubbed ‘Article Pfizer’ by critics, represents a significant shift in the balance between public health policy and individual freedom of expression, says Robert Kogon, the pseudonym of a writer for the U.K. website The Daily Sceptic.
“The legislation in question has prima facie nothing whatsoever to do with mRNA drugs, but is devoted rather to the fight against so-called ‘sects’ or ‘sectarian tendencies,’” said Kogon. “Even if just limited to religious ones, incidentally, it is hard to see how an officially-promulgated ‘fight’ against sects or ‘sectarian tendencies’ is compatible with freedom of conscience.”
‘It’s the Big Lie’
How bad does it have to get before somebody says, “Hold on a minute,” asks John Dale Dunn, M.D., J.D., a physician and policy advisor to The Heartland Institute, which publishes Health Care News.
“This is totalitarian, authoritarian, autocratic government by a bunch of people who are not scientifically informed enough to make these decisions, but who have decided to do what they’re told by the army of experts who have designated themselves as the experts even though they have ignored the research that shows what they’re claiming is not true,” said Dunn.
“It’s the Big Lie,” said Dunn. “They’re pushing the Big Lie, and the way that they get it done is they criticize, condemn, punish, or censor anyone who objects to the Big Lie.”
“People need to wake up to the fact that we have a totalitarian, political entity running the United States at this point that’s called The Uniparty,” said Dunn. “So, what it comes down to is all the things you see that are going on in Europe, and why there’s no big outcry by the politicians and the media in the United States, [it] is because they want to adopt the same kind of approach here.”
‘Bad for the Soul’
It is hard to believe that such a law could be considered, much less passed, in a country claiming to be free or democratic, says Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons.
“It gives unbridled dictatorial power to government, with no accountability or recourse for injury or death to unwilling recipients of a medical intervention,” said Orient. “Calling it the ‘Pfizer amendment’ is totally appropriate.”
It appears that government officials have been threatened or bribed by a mammoth private entity to sacrifice their constituents—in the process destroying the trustworthiness of scientists and medical professionals—to a profit-hungry corporation that has already paid billions of dollars in criminal fines, says Orient.
“Persons of integrity, be they medical workers, journalists, or even elected officials, could be bankrupted or imprisoned, while citizens are at the mercy of brainwashed, corrupt, power-hungry apparatchiks,” said Orient. “Staying in France is bad for your life, your health, and your soul.”
‘Dialogue Is Crucial’
Although the new French law may not be as draconian as some suggest, it does fit into the larger question of health policy and freedom, and certainly those in the public health profession who seek to go beyond the limits of experts in a free society, says Daniel Sutter, Ph.D., the Charles G. Koch Professor of Economics with the Manuel H. Johnson Center for Political Economy at Troy University.
“Experts should not make decisions for citizens; rather they should help inform citizens of the advantages and disadvantages of proposed courses of action, clearly letting the citizen ultimately decide what is best for himself or herself,” said Sutter.
Also, shutting down or criminalizing differences of opinion really impairs our ability to learn as a society, says Sutter.
“We need to let dissenting experts, in particular, criticize the rules recommended by government agencies,” said Sutter. “We know politics, and not science, can influence all government health recommendations. And government experts might share similar biases and are failing to recognize some costs.
“When outside experts dissent from the recommendations, what we as citizens learn is that the recommendations may not be as solid as the government experts think, and there may be some patients for whom outside experts (doctors) realize the recommended treatment or vaccine may not be best for,” said Sutter. “This dialogue is crucial in societal learning and needs to be preserved.”
Voluntary Choice Better Than Force
“Finally, I think pharmaceutical companies should rethink their long-term position relative to getting government to mandate their treatments or vaccines,” said Sutter.
“Markets are based on voluntary choices and Big Pharma would be better served by trying to truly market their products instead of forcing them on people. It’s easy to boost sales short term through government mandates but, longer term, consumers no longer view your companies as truly part of the market, as products meant to make consumers’ lives better.”
From The Recycling Bin To The Landfill: The Major Flaw In Plastic Recycling
by Cara Michelle Miller via The Epoch Times (emphasis ours),
People may be putting plastic into recycling bins, but most of it generally ends up in landfills or incinerated.
Yet the demand for more plastic production continues—at a growing cost to human and environmental health—because of the belief that recycling offsets the associated waste and risks. A new report by the Center for Climate Integrity (CCI) alleges that the plastics industry knowingly caused the current plastic waste crisis.
The nonprofit’s report claims that as the plastics industry faced mounting concerns over plastics being incinerated and piling up in landfills, they promoted recycling as a viable solution while dismissing it internally as impractical.
“They knew since the 1970s that plastic recycling was not going to be scalable and effective in tackling the plastic waste crisis,” Melissa Valliant, communications director of Beyond Plastics, a nonprofit aiming to reduce single-use plastic use and production, explained to The Epoch Times.
The report asserts that the efforts to sell the false promise of plastic recycling were to avoid restrictive regulations and potential product bans.
Plastic Recycling Poses Many Challenges
According to the report, one problem with plastic recycling is that it is not technically or economically feasible at scale. Unlike glass and metal, plastic cannot be repeatedly recycled without quickly degrading in quality. Most recyclable plastics can typically only be recycled once. As a result, most recycled plastic eventually ends up in landfills, even if it goes through an additional use cycle as another product.
Between the 1970s and 2015, 91 percent of plastic was either landfilled, burned, or leaked into the environment, according to a global analysis published in Science Advances. Another recent report published by Beyond Plastics estimated that less than 6 percent of plastic in the United States is successfully recycled.
These figures are based on all plastic waste generated, which includes plastics not made to be recycled and those thrown away. As for the plastic that makes it to a recycling center, there isn’t an official nationwide estimate of what percent of those plastics get recycled in the end.
However, certain types of plastic containers—soda and water bottles (PET 1) and milk jugs (HDPE 2), in particular—are more likely to be recycled.
The Organisation for Economic Co-operation and Development (OECD), an international organization focused on improving public policies, says only 9 percent of plastic collected for recycling worldwide in 2019 was actually recycled; 50 percent went into landfills, and 22 percent was mismanaged.
Another challenge is that there are too many different types of plastics. Recyclable plastics cannot be recycled with plastics made of different chemical compositions, and sorting the waste is infeasible.
Decades of Misleading Messaging
The plastics industry’s actions “effectively protected and expanded plastic markets,” the CCI report states, “while stalling legislative or regulatory action that would meaningfully address plastic waste and pollution.”
The report, highlighting industry communications and documents, details how, beginning in the 1950s, the plastics industry’s profits soared with single-use disposable plastics, and this “shift to disposables” created the waste problem.
In response, the industry promoted landfilling and incineration. However, by the 1980s, the plastics industry faced growing backlash and legislation to limit the sale of single-use plastics because of pollution and its environmental impact.
The industry “launched multimillion-dollar ad and PR campaigns to convince the public consumer that this was a consumer problem; just put the right things in the bin, and all the plastic pollution would go away,” said Ms. Valliant.
Plastic production then skyrocketed, from approximately 2 million tons of plastic in the 1950s to nearly 460 million tons in 2019, and continues to rise.
The CCI report cites a 1986 report by Vinyl Institute, a trade association, that “recycling cannot be considered a permanent solid waste solution [to plastics], as it merely prolongs the time until an item is disposed of.”
Eight years later, an Exxon employee warned the American Plastics Council staffers that they did not “want paper floating around” saying they could not meet recycling goals since the issue was “HIGHLY SENSITIVE POLITICALLY.”
The report’s authors aim to hold fossil fuel and other petrochemical companies accountable by pointing out that these admissions contradict decades of messaging promoting recycling.
Plastics Companies Cite New Technologies, Goals
Twenty petrochemical companies, including major oil and gas companies such as ExxonMobil, manufacture half of the world’s single-use plastics, according to the CCI.
In response to the CCI report, the Plastics Industry Association characterized the report as “political attacks” and that it is based on “outdated information and false claims.”
“This report was created by an activist, anti-recycling organization and disregards the incredible investments in recycling technologies made by our industry,” Matt Seaholm, president and chief executive officer of the Plastics Industry Association, said in the press statement.
Similarly, in a statement published by the American Chemistry Council (ACC), Ross Eisenberg, the president of America’s Plastic Makers, called the report flawed, saying it “cites outdated, decades-old technologies, and works against our goals to be more sustainable by mischaracterizing the industry and the state of today’s recycling technologies.” He also pointed to the benefits of plastics and how they can be reused to meet different needs.
“We’ve set an ambitious goal for all US plastic packaging to be reused, recycled, recovered by 2040, and we are working towards this goal by supporting systems and technologies that remake new plastics from used plastics,” he shared.
But many wonder: Even if the ACC’s 2040 goal is met, does it solve the wide-ranging issues linked to plastics?
Is Recycling Enough?
“Possibly more concerning than the environmental impacts are the health impacts of plastics on the human body,” said Ms. Valliant, who recommends consumers focus on efforts to reduce, reuse, recycle, and, when possible, refuse single-use plastic.
The management of plastics “needs to be addressed at a higher level than the individual,” Mathew Campen, a toxicologist from the University of New Mexico, told The Epoch Times.
When plastic is recycled improperly, it ends up not only in landfills and water sources but also in our soil, air, and even our bodies. Every day, we eat, drink, and inhale tiny bits of plastic because plastic doesn’t biodegrade over time—it simply breaks down into ever-smaller particles.
Mr. Campen, who investigates the impact of environmental toxicants on human health, is concerned about the increasing amount of plastics, specifically microplastics, in the environment and the potential effects.
“The truth is, governments and industry need to figure out a path to actually take care of this waste and not have it show up in our bodies,” he added.
https://www.zerohedge.com/political/recycling-bin-landfill-major-flaw-plastic-recycling