Cell therapy biotech FibroBiologics selects January 31 for Nasdaq direct listing date

 FibroBiologics, a Phase 1 biotech developing fibroblast-based therapies for chronic diseases, is expected to begin trading on the Nasdaq on Wednesday, January 31, 2024.

The Registered Stockholders plan to sell up to 4.8 million shares. Between April and September 2023, FibroBiologics sold the equivalent of about 75 thousand shares at prices ranging from the equivalent of $18 to $20.

Spun out of former parent FibroGenesis in 2021, FibroBiologics is focused on developing fibroblast-based therapies for patients suffering from chronic diseases with significant unmet medical needs, including degenerative disc disease, multiple sclerosis (MS), wound healing, and certain cancers. Its most advanced product candidates are CybroCell, an allogeneic fibroblast cell-based therapy for degenerative disc disease, and CYMS101, an allogeneic fibroblast cell-based therapy for MS. FibroBiologics has received IND clearance from the FDA for a Phase 1/2 study of CybroCell in degenerative disc disease in the US, conditional upon approval of its master cell bank. The company completed a Phase 1 study of CYMS101 in MS in Mexico, and expects to file an IND application for a Phase 2 trial.

None of the company's shareholders will be subject to the standard 180-day lock-up agreement found in most IPOs.

The Houston, TX-based company traces its roots to 2006 and plans to list on the Nasdaq under the symbol FBLG. As a direct listing without a firm commitment offering, there are no underwriters on the deal; instead, Maxim Group LLC will serve as a financial advisor.

Relevant Profile: FBLG

https://www.renaissancecapital.com/IPO-Center/News/102920/Cell-therapy-biotech-FibroBiologics-selects-January-31-for-Nasdaq-direct-li

Consent Is Needed Even for Training: Ethicist

 Hi. I'm Art Caplan. I'm at the Division of Medical Ethics at NYU Grossman School of Medicine.

For a long time in medicine, people who were learning to do intimate exams, such as pelvic exams, prostate exams, and rectal exams, learned to do so on patients who were undergoing procedures that required them to be put under anesthesia.

I think many people felt that if you're getting procedures done, let's say in a teaching hospital, then you forfeit your right to say yes or no. These exams are not going to harm you and it's important that students learn how to perform them and do them properly for the health of future patients. That's what teaching hospitals do.

Many places in the US, Canada, and elsewhere had a long history of doing this kind of examination without the consent — almost always of women but occasionally of men — to perform teaching of this intimate examination. Frequently, the patient never knew that kind of teaching or the intervention had been done. They weren't even aware.

I've long felt that using a patient in this way, without their permission or consent, even in a teaching hospital setting, is flat-out wrong. Sometimes we get gray zones in ethics where you can make a case for one side or the other. I don't see it here. I think you need permission from the patient before they undergo anesthesia, or even when they're conscious, that they're willing to serve as someone you train upon to do this kind of an exam.

It obviously has significant sensitivity in our culture. There are people who've been charged with sexual abuse for doing the same thing on a nonconsenting woman. That's viewed as criminal. I don't think that's the risk here, but I do think we lose trust and we lose a patient's confidence if we're found out to be doing this kind of examination with no permission.

Pennsylvania recently became the 20th state to pass a law demanding both written and oral consent prior to any type of examination, whether it involves anesthesia or not, for training purposes. Connecticut, where I live, passed a law last year that I was active in trying to push through the legislature here, and we got it.

I think asking patients, "Is it alright if we examine you and use that to teach students, either when you're conscious or when you undergo anesthesia for some other procedure?" is the way to go. Even in states that don't have those laws, I think that should be what we're doing.

I also believe that the number of people who say yes is surprisingly high. I've had the opportunity to track a little bit of the impact in Connecticut, and there doesn't appear to be much change in the willingness of people to make themselves available for this kind of teaching. Most patients actually want to help; they want to help the next generation of doctors learn. They know that they might be undergoing an examination that maybe could reveal something that wasn't suspected. There could be a tiny benefit in these exams for them.

Even if you don't get permission in the numbers expected, there are professional patients who, for pay — the pay isn't huge — will be happy to undergo examination as part of what they understand as important work to teach the next generation of doctors.

In sum, I don't think the practice of surreptitious, intimate examination, or any form of examination, should go on; I think we're at a point with informed consent where patients have the right to expect that they're going to be asked and give permission when something is undertaken that isn't part of their standard treatment.

I also think we ought to give patients the right to participate. As I said, at least in my state, the overwhelming majority of patients want to participate and help. Respecting that noble choice is something that bonds us with our patients and makes for a common cause in the battle against illness and disease, rather than being seen as people who might be doing things that are not trustworthy, sneaky, somehow shameful, and not even brought up with the patient.

That's not the position that medicine wants to be in if we want to keep securing trust from our patients.

https://www.medscape.com/viewarticle/999358

Rheumatoid Arthritis Disease Activity Assessed Too Little After Starting TNFi

 

TOPLINE:

Less than half of patients with rheumatoid arthritis (RA) initiating a first-line tumor necrosis factor inhibitor (TNFi) in clinical practice had a recorded composite disease activity assessment at the start of the treatment, and many remained on that treatment for years without evidence recorded in their electronic medical record of achieving low-disease activity or remission.

METHODOLOGY:

• Researchers reviewed data from 1651 adults aged 18 years and older with moderate to severe RA at baseline or follow-up in the electronic medical record database of the American Rheumatology Network, a large community network of independent practices with > 200 rheumatologists across the United States.
• Patients received a TNFi as their first advanced therapy between January 2014 and August 2021 and were assessed for measurement of disease activity with the Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3) at baseline and follow-up visits.

TAKEAWAY:

• Among the patients with moderate to severe RA, 47.2% of patients remained on first-line TNFi therapy 1 year after initiation despite no evidence of achieving treatment targets of low disease activity or remission (defined as CDAI ≤ 10 and/or RAPID3 ≤ 2).
• Approximately one third of patients remained on TNFi therapy for 2 (38.1%) or 3 (35.4%) years after initiation despite not achieving these targets. The median times to TNFi discontinuation was 30.4 months and to subsequent therapy initiation 68.3 months.
• A total of 52% discontinued their initial TNFi during the study period; among those who started a second therapy, 15% restarted the same TNFi, 45.6% started another TNFi, 27.6% started a non-TNFi biologic, and 11.5% started a Janus kinase inhibitor.
• The most common reported reasons for discontinuation were a combination of efficacy and intolerance, efficacy only, and intolerance only (26.9%, 25.3%, and 20.3%, respectively).
• Persistent pain was the most common reason for efficacy-related discontinuation (39.0%), followed by persistent inflammation/swelling and overall general discomfort (31.8% for both).

IN PRACTICE:

"Consistent monitoring of treatment response and timely switch to effective therapy as appropriate is needed in patients with RA initiating their first advanced therapies," the researchers wrote.

SOURCE:

First author Colin Edgerton, MD, of Articularis Healthcare Group and American Rheumatology Network, Charleston, South Carolina, reported their work on January 14, 2024, in ACR Open Rheumatology.

LIMITATIONS:

The findings were limited by several factors including the retrospective design, incomplete data from electronic medical records, and reliance on physician documentation for drivers of discontinuation.

DISCLOSURES:

The study was supported by AbbVie. Lead author Edgerton also disclosed relationships with Novartis and Boehringer Ingelheim.

https://www.medscape.com/viewarticle/ra-disease-activity-assessed-too-little-after-starting-tnfi-2024a10001qv

UK: Pandemic Left Obesity Legacy Among Schoolchildren

 Lockdown measures during the COVID-19 pandemic contributed to sharp increases in the number of obese and overweight primary school children in England that could lead to additional healthcare costs running into millions of pounds over their lifespan, researchers have estimated.

Previous research has suggested that children were at particular risk of weight gain in 2020-2021 as schools closed, organised sport was cancelled, and opportunities for physical recreation were curtailed. Pandemic restrictions may also have caused a deterioration in healthy eating habits, disrupted sleep, and increased children's screen time, according to researchers at the University of Southampton who carried out the investigation.

The researchers used data on childhood BMI from the National Childhood Measurement Programme for children aged 4-5 years in reception classes and those aged 10-11 years who were finishing their primary education.

The analysis found that prevalence of overweight and obesity among children in reception year rose from 9.9% in 2019-2020 to 14.4% in 2020-2021, and decreased to 10.1% in 2021-2022, returning to the pre-pandemic trend. 

However, overweight and obesity prevalence in children aged 10-11 years persisted and was 4% higher than expected. This increase meant that 55,838 more primary schoolchildren could have become overweight or obese during the pandemic, with 16,752 of those being severely obese, according to the research.

The increase was twice as high among children from the most deprived areas of the country compared with the least deprived, with particularly high rates among those from Black and South Asian backgrounds.

Study co-author Keith Godfrey, professor of epidemiology and human development at the University of Southampton, explained to Medscape News UK: "We think that in the older children, the obesity is more embedded, in that the health-related behaviours which underlay the COVID-associated rise were more persistent. So, in young children, they go back to better diets and more physical activity, whereas by the end of primary school, once the children have changed their behaviours, they are much less likely to go back to the healthier behaviours that they had before."

The authors of the study, published in PLOS ONE, estimated that the additional healthcare cost for this cohort could amount to £800 million for treatment of persistent obesity and other long-term conditions such as type 2 diabetes, hypertension, and coronary artery disease. 

The wider costs to society could amount to £8.7 billion, according to the researchers. "The NHS costs of obesity are about a fifth of the total costs to society through sickness absence, and all the rest of it that goes with it," said Godfrey.

The study authors concluded: "Our data raise profound social justice, equity, and financial concerns, with pressing implications for individuals, policymakers, and UK society. Obesity prevalence in the most deprived areas of England is now more than double that in the least deprived and the gap has been widening over time."

Katharine Jenner, director of the Obesity Health Alliance, who was not involved in the study, told Medscape News UK that the small decline in overweight and obesity prevalence among younger primary schoolchildren suggested that improvements were possible, "but they will not drop further without political will from the highest levels of government". 

Jenner commented: "We have laws in place that could immediately help children in disadvantaged circumstances to grow up healthily, such as only allowing healthier food to be on price-promotion, advertised on TV, or online. But the government has needlessly delayed them coming into force until the end of 2025 – leaving more and more children to suffer the consequences of inaction."

Godfrey said: "Frankly, the measures that are currently in play are not sufficient to reverse these worrying trends – which are ongoing – in the disparities in childhood obesity between those living in the most and least advantaged areas."

https://www.medscape.com/s/viewarticle/pandemic-left-obesity-legacy-among-school-children-2024a10001ra

HPE says it was hacked by nation-state actor Midnight Blizzard

 Hewlett Packard Enterprise Co. (HPE) said Wednesday that a suspected nation-state actor hacked its cloud-based email system. The organization is "believed to be the threat actor Midnight Blizzard, the state-sponsored actor also known as Cozy Bear," HPE said in a regulatory filing. Last week, Microsoft Corp. (MSFT) said the same group gained entry to its network and accessed "a very small percentage of Microsoft corporate email accounts." Both companies determined the cyber-intrusions did not materially impact operations.

https://www.morningstar.com/news/marketwatch/20240124565/hpe-says-it-was-hacked-by-nation-state-actor-midnight-blizzard

US Launches Airstrikes In Somalia For First Time This Year

 by Dave DeCamp via AntiWar.com,

The US launched airstrikes in Somalia on January 21, US Africa Command announced on Tuesday, marking the first known US bombing of the country in 2024.

AFRICOM said in a press release that the strikes consisted of two separate engagements against al-Shabaab about 20 miles northeast of Kismaayo, a port city in southern Somalia. The command said the strikes were launched at the request of the US-backed Mogadishu-based government.

The command said its "initial assessment" found three al-Shabaab fighters were killed and claimed no civilians were harmed. But AFRICOM is notorious for undercounting civilian casualties, and US military operations in Somalia are shrouded in secrecy.

The last US airstrikes in Somalia reported by AFRICOM were launched on December 20. The latest US bombing comes as tensions are soaring off the northern Somali coast as the US has launched a new war against Yemen’s Houthis in response to their attacks on Israel-linked commercial shipping that started in protest of Israel’s onslaught in Gaza.

US airstrikes in Somalia escalated in 2022 after President Biden ordered the deployment of up to 500 troops to the country, and the US-backed government launched an offensive against al-Shabaab.

When the House debated a resolution to withdraw from Somalia last year, lawmakers said there were 900 troops in the country. US troops on the ground in Somalia provide training for a special fighting force known as the Danab Brigade.

US operations in Somalia under Biden have not gotten as intense as they were during the Trump administration when the US bombed the country at a record pace.

The US military hypes the threat of al-Shabaab due to its size and al-Qaeda affiliation, but it’s widely believed the group does not have ambitions outside of Somalia. Al-Shabaab was born out of a US-backed Ethiopian invasion in 2006 that toppled the Islamic Courts Union, a coalition of Muslim groups who briefly held power in Mogadishu after ousting CIA-backed warlords.

Al-Shabaab was the radical offshoot of the Islamic Courts Union. The group’s first recorded attack was in 2007, and it wasn’t until 2012 that al-Shabaab pledged loyalty to al-Qaeda after years of fighting the US and its proxies.

https://www.zerohedge.com/geopolitical/us-launches-airstrikes-southern-somalia-1st-time-year

Biden's New Houthi Strategy "Like Trying To Find Needle In Haystack, While Eating Truffles And Foie-Gras"

By Michael Every of Rabobank

The New Hampshire Republican primary saw Donald Trump beat Nikki Haley, though by how much was unclear at time of writing, as some pundits say a chunk of Republican primary voters were actually Democrats – ‘shenanigans’. Regardless, with Haley refusing to drop out, on to South Carolina we roll on February 24. President Biden also won his contest vs. the outsider Dean Philips without doing any campaigning, for those who had forgotten there is a partial Democratic primary process too. The markets can chew on that all at their leisure today: so far it’s taken as dollar up, yields up at the margin.

The BOJ saw no change, but rate hikes were put back on the menu as soon as April by Governor Ueda’s press conference. As a result, Asia’s Wednesday starts with the US dollar up (DXY at 103.6) and Treasury yields mixed (2s at 4.34%, -7bp from their intra-day peak Tuesday, 10s at 4.14%, close to that peak), and US stocks a baseball cap lower at ‘Dow 37,905!’, but with 10-year JGBs up to 0.72%. While well below the peak of 0.96% back in November, that’s still vs. 0.55% in the middle of January.

China’s proposed $278bn stock bailout, taking offshore cash holdings of profitable SOEs and buying the shares of firms that don’t make money, has seen what Bloomberg calls a “wall of market scepticism”. Indeed, the plan offers those who are still allowed to sell the opportunity to do so, and as @BaldingsWorld notes, it’s “like getting a chocolate shake after your girlfriend dumps you after finding your parents got murdered.” Indeed, Reuters notes China's plunging stocks are triggering losses on billions of linked derivatives, forcing a vicious cycle of selling in both. Question: What’s a Leninist response to “financial oligarchy” – or do we just get QE?

On which, ‘Christine Lagarde makes a poor central banker, ECB staff say’. 50.6% of those surveyed ranked her performance as “very poor” or “poor” vs. less than 10% for her predecessor Draghi. Specific complaints include her “being an autocratic leader who does not necessarily act according to the values she proclaims,” who is “wading too deeply into politics and using the ECB to boost her personal agenda,” although there are no problem with green issues, just gender and geopolitics, and several respondents suggest Lagarde wants to use the bank as a “springboard back into French politics”. We’d never see that happen, surely? (**cough** Draghi and Yellen **cough**) On monetary policy, only 38% of respondents backed the rate decisions taken under Lagarde: so they didn’t want to raise rates, or thought they were raised too slowly? Worse, over half the ECB staff respondents said they were concerned it won’t be able to deliver a return to price stability. And developments in the world of geopolitics which the staff think Lagarde shouldn’t talk about support their scepticism.

An Israeli proposal for a two-month ceasefire in exchange for the release of all hostages was rejected by Hamas: an offer is now being made for a one-month pause, but the issue of an official surrender is a likely stumbling block. The deaths of 24 Israeli troops yesterday, the highest one-day toll since 10/7, are likely to increase, not decrease its focus on uprooting Hamas.

Moreover, the US and UK -- now backed by 24 nations, all of whom are just holding signs saying “applause”-- again bombed the Houthis, as the US alone struck Iran-backed militia in Iraq. However, the White House’s lack of strategy is evidenced by another Politico article, ‘How to stop the Houthis’, which notes:

“The US attacks on Houthi targets will degrade the militants’ abilities to keep shooting at ships, as will the interdiction of vessels carrying weapons to Yemen. Last week’s redesignation of the Houthis as terrorists will increase the sanctions pressure on them, starving fighters of the resources that bankroll operations. Eventually, the official continued, regional countries and other nations with an interest in open sea lanes --China, for example-- will demand an end to the shipping crisis that has inflated prices and imperilled lives. Meanwhile, Israel’s plan for more targeted operations in Gaza could mean fewer civilian casualties, which would weaken the Houthis’ case for rising to the Palestinians’ defence. An end to the war would remove that rallying cry.”

So, in reverse order, the ‘plan’ relies on:

1. A quick resolution to the Israel-Palestine problem(!), and a scaling back of the war when escalation to other front via Hezbollah is still a threat.

2. Overlooking that while China’s exporters are hurting from this crisis -- which makes the case for onshoring/near-shoring-- it’s also watching a steady erosion in US global standing, deterrence, and key munition levels, and Europe is exposed as very vulnerable – a stagflationary recession there would make cheap Chinese imports even more attractive vis-à-vis local goods. Moreover, China just launched a new shipping line specifically promoting its ability to sail through the Red Sea unhindered.

3. On sanctions, the Houthis get help from Iran: so will Iran be sanctioned, and secondary sanctions placed on those who break them, as some already are?

4. Military strikes vs. movable Houthi targets are like trying to find a needle in a haystack, while eating truffles and foie-gras, given the very high cost involved.

Indeed, Politico admits, “Even if all those various elements lined up,” --which they likely won’t-- ”it’s still not clear the strategic picture the Houthis care about will shift radically enough for a course correction.” More pointedly, the Middle East Institute’s Charles Lister notes, “There’s no denying the lack of strategic clarity right now,” and a former Middle East peace negotiator quoted shows those skills in adding, “They have no magic fix. Often the choice is not between a great and a bad option. It’s between a bad option and one that’s worse.”

In the meantime, almost all the world’s largest container ships are going round the Cape of Good Hope, not via Suez, and we see warnings of ‘Covid revisited: Empty container concerns grow as Red Sea shipping crisis drags on’.

In short, the people running US national security policy might as well be setting ECB rates, and Lagarde directing the military. In the eyes of their own staff, neither of the two institutions look to be doing what’s needed to deliver a 2% CPI target.

https://www.zerohedge.com/markets/bidens-new-houthi-strategy-trying-find-needle-haystack-while-eating-truffles-and-foie-gras