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Wednesday, April 28, 2021

Galectin Therapeutics to Present at 4th Global NASH Congress

  Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that Pol F. Boudes, M.D., Chief Medical Officer, will present the belapectin program at the 4th Global NASH Congress taking place virtually on April 28 and 29, 2021.

On Thursday, April 29th, Dr. Boudes will review Galectin Therapeutics’ scientific and clinical activities in NASH cirrhosis, followed by a Q&A session. Only registered attendees are able to view the presentation. Additional details can be found below:

Title: An innovative clinical development program: belapectin for NASH cirrhosis
Date: Thursday, April 29, 2021
Time: 11:45 am, British Summer Time, 6:45 am Eastern

Belapectin, a galectin-3 (Gal-3) inhibitor, is in development for the prevention of esophageal varices in patients with NASH cirrhosis. Patients with cirrhosis are in dire need of new therapeutic options as, currently, their only hope is a liver transplant. Gal-3, a glycan binding protein, orchestrates liver inflammation and fibrosis in NASH cirrhosis. Belapectin is a large polysaccharide that binds Gal-3 and is primarily captured by macrophages, thus inhibiting Gal-3 at its main site of production.

A phase 2 study indicated that belapectin appeared safe, was well tolerated, and could reduce portal hypertension and prevent esophageal varices in patients who have not yet developed them. Galectin is conducting a seamless, adaptive, double-blind, randomized, placebo controlled phase 2b/3 global study in patients with portal hypertension due to NASH cirrhosis who have not yet developed varices. The primary outcome is the development of esophageal varices at 18 months.

The annual Global NASH Congress, usually held in London, will be taking place virtually on April 28 and 29, 2021. The conference aims to facilitate collaboration among the multiple communities working on liver health, especially those researching non-alcoholic steatohepatitis (NASH) and fatty liver disease (NAFLD). To learn more, visit: http://www.global-engage.com/event/nash/.


Regional Health free cash flow from continuing operations positive despite COVID headwinds

 Despite some headwinds from COVID-19, executives at Regional Health Properties feel hopeful about the nation’s vaccine efforts and occupancy recovery in the second half of the year, according to the firm’s fourth-quarter and year-end 2020 earnings results, released after the market closed on Thursday.

The Atlanta-based real estate investment trust reported that it had terminated a lease with the operator of two non-performing facilities in Georgia and transitioned one of them to new operators. Preliminary results for transitioned facilities for January and February are encouraging, according to the firm. In addition, Regional collected 91% of its 2020 cash rent and generated positive free cash flow from continuing operations for the fourth quarter and year end.

“Our portfolio occupancy experienced some softness going into year end but we remain hopeful that the vaccine rollout and reinstating family visitation privileges should reverse the downward trend by the second half of 2021,” said Brent Morrison, Regional Health Properties’ president and CEO. “We have a strong and experienced portfolio of operating partners and remain confident in their abilities to continue to navigate through the challenges resulting from the ongoing pandemic.” 

Regional’s new chief financial officer, Ben Waites, who joined the firm in September, also expressed confidence in Regional’s financial stability.

“I’m excited to join the Regional team,” he said in a statement. “I look forward to furthering the company’s progress and see Regional well positioned to weather the storm. We see opportunities to refinance some of our senior debt secured by U.S. Department of Housing and Urban Development, as well as other capital structure improvements.”

https://www.mcknightsseniorliving.com/home/news/business-daily-news/regional-health-generates-positive-free-cash-flow-from-continuing-operations-despite-covid-19-headwinds/

US ups funding for Moderna Covid-19 vaccine as total nears $6B

 The US government poured money into Moderna as it sought to speed its Covid-19 vaccine to market. In hindsight, the investments worked, and the US may end up investing about $6 billion in Moderna’s vaccine when all is said and done, according to a company SEC filing Wednesday.


The latest funds from the Biomedical Advanced Research and Development Authority, up to $236 million more, will reimburse for Moderna’s costs associated with the vaccine’s Phase III clinical trial, as well as pharmacovigilance efforts to track the vaccine’s safety.


The increase in government reimbursements come as the company estimates it’ll collect at least $18.4 billion from sales of its Covid-19 vaccine this year.


That expected windfall follows the government’s investments of another $5.75 billion into the vaccine’s development, clinical trials, manufacturing and purchase of 300 million doses, all since last April. The company has already delivered 100 million doses to the US government, and another 100 million are expected before the end of next month, while another 100 million doses are slated for the end of July.


As of the end of March, Moderna said $317 million remained available under the BARDA contract, prior to this additional $236 million. The contract also spells out exactly what Moderna can request reimbursements for and all of those requests are reviewed by BARDA in detail.


The government’s investment and Moderna’s rise have brought instant riches to its earliest investors, with Flagship selling off $1.4 billion in Moderna shares, and the company’s executives.


CEO Stéphane Bancel is now worth more than $5.5 billion, and he sold $161 million in shares of Moderna, while outgoing CMO Tal Zaks cashed in $101 million in shares.

https://endpts.com/us-ups-funding-for-moderna-covid-19-vaccine-as-total-nears-6b/

Privia Health Group increases range to $21 to $23 ahead of $429 million IPO

 Privia Health Group, which provides a value-based care platform for physicians, raised the proposed deal size for its upcoming IPO on Wednesday. 


The Arlington, VA-based company now plans to raise $429 million by offering 19.5 million shares (86% insider) at a price range of $21 to $23. The company had previously filed to offer the same number of shares at a range of $17 to $19. The company may raise an additional $92 million in a private placement to Anthem, which is expected to close on or up to 30 days after the closing of the offering. At the midpoint of the revised range, Privia Health Group will raise 22% more in proceeds than previously anticipated.

Privia's platform is powered by its proprietary end-to-end, cloud-based technology solution that integrates both Privia-developed and third-party applications into a seamless interface and workflow that manages all aspects of healthcare services. The company currently operates in six states and the District of Columbia, covering over 70 target metropolitan statistical areas (including 20 out of the largest 100 MSAs). More than 2,770 Privia Providers had signed to join its platform as of December 31, 2020, including approximately 2,550 Privia Providers who are credentialed and bill for health care services through its Medical Groups ("implemented providers"). Its implemented Privia Providers operate in over 650 care center locations providing care to over 3 million patients.

Privia Health Group was founded in 2007 and booked $817 million in revenue for the 12 months ended December 31, 2020. It plans to list on the Nasdaq under the symbol PRVA. Goldman Sachs, J.P. Morgan, Credit Suisse, Piper Sandler and William Blair are the joint bookrunners on the deal. It is expected to price during the week of April 26, 2021. 

BioNTech boss: Europe will reach herd immunity this summer

 Europe can achieve herd immunity against the coronavirus within three to four months, the head of German pharmaceutical company BioNTech, which developed the first widely approved COVID-19 vaccine with U.S. partner Pfizer, said Wednesday.

While the exact threshold required to reach that critical level of immunization remains a matter of debate, experts say a level above 70% would significantly disrupt transmission of the coronavirus within a population.

“Europe will reach herd immunity in July, latest by August,” Ugur Sahin, BioNTech’s chief executive, told reporters.

He cautioned that this herd immunity initially wouldn’t include children, as the vaccine has so far only been approved for people over 16. A small number of children who fall ill with COVID-19 suffer serious illness or long-term effects.

BioNTech’s vaccine makes up a large share of the doses administered in North America, where it is more commonly known as the Pfizer shot, and Europe, which has been seen vaccination rates rise after a slugging start.

Sahin said data from people who have received the vaccine show that the immune response gets weaker over time, and a third shot will likely be required.

Studies show the efficacy of the BioNTech-Pfizer vaccine declines from 95% to about 91% after six months, he said.

“Accordingly, we need a third shot to get the vaccine protection back up to almost 100% again” Sahin said.

Vaccine recipients currently receive a second dose three weeks after their first shot, although some countries have longer intervals. Sahin suggested the third should be administered nine to 12 months after the first shot.

“And then I expect it will probably be necessary to get another booster every year or perhaps every 18 months,” he said.

Concerns have been raised that existing vaccines might be less effective against new variants of the virus now emerging in different parts of the world.

Sahin said BioNTech has tested its vaccine against more than 30 variants, including the now-dominant one first detected in Britain, and found the shot triggers a good immune response against almost all of them in the lab. In cases where the immune response was weaker, it remained sufficient, he said, without providing exact figures.

Asked about the new variant first detected in India, Sahin said the vaccine’s effectiveness against it was still being investigated.

“But the Indian variant has mutations that we have previously investigated and against which our vaccine also works, so I am confident there, too,” he said.

The Mainz-based company’s work developing a vaccine based on messenger RNA, or mRNA, benefited from its earlier research into pharmaceuticals to treat cancer, as tumors often try to adapt to evade the immune system, Sahin said.

“The way our vaccine works is that it has two points of attack,” he explained. Along with stimulating the production of antibodies, it prompts the body’s so-called T-cells to attack the virus, he said.

“The vaccine is quite cleverly constructed, and the bulwark will hold. I’m convinced of that,” Sahin said. “If the bulwark needs to be strengthened again, we’ll do so. I’m not worried.”

The company is investigating reports of heart inflammation cases in people who received the vaccine in Israel, but so far hasn’t seen any data that would indicate a heightened risk, Sahin said. Some 5 million people in Israel have been vaccinated, primarily with the BioNTech/Pfizer shot, giving it one of the highest coverages in the world.

“We take everything we hear very seriously,” Sahin said. “The most important principle in drug development is to do no harm.”

BioNTech expects to receive approval in July for its vaccine to be used in China, where it cooperates with local firm Fosun Pharma, he said.

Meanwhile, BioNTech and Pfizer are working with other manufacturers to ramp up production of the mRNA shot as worldwide demand still far outstrips supply.

“When we started 2021, our goal was to produce 1.3 billion doses, and now we’ve increased that to 3 billion doses,” said Sahin, praising pharmaceutical giants such as Novartis, Sanofi and Baxter for joining in the effort.

His company is in talks to create production facilities in Asia, South America and Africa, and may also issue special licenses to other “really competent” manufacturers to boost global supply of the vaccine, Sahin said.

“We don’t want to have a low-quality vaccine in Africa,” he added, dismissing suggestions that the recipe for it could simply be made freely available.

Countering fierce criticism that the European Union had bungled its vaccine procurement process, Sahin said the 27-nation bloc deserved praise for managing to coordinate the simultaneous delivery of the first batches to all member states at the end of December.

“Europeans can be proud that they found a fair solution,” he said, adding that the bloc also exported large numbers of doses elsewhere.

“It doesn’t help if Europeans are safe and other countries, where the virus is still raging, keep churning out new variants,” he said.

Sahin founded BioNTech in 2008 with his wife, the scientist Ozlem Tureci. Together they decided to pivot from cancer research to developing a coronavirus vaccine in early 2020 and reached out to Pfizer, which had the necessary expertise to conduct large-scale clinical trials.

The 55-year-old, whose family emigrated from Turkey to Germany when he was 4, told members of Germany’s foreign press association VAP that it was “a very nice feeling” to be hearing of more and more people who are able to finally see loved ones again after getting vaccinated with his company’s shot.

Sahin said he expects a “new normal” soon, where “one can move about freely and most people have a very good immune protection” against the virus.

Even so, some people would either not want to get vaccinated or have a weak immune system “and we have to consider these people too,” he said.

https://apnews.com/article/europe-north-america-immunizations-coronavirus-pandemic-coronavirus-vaccine-f1eca91561f3a1be9550b79534b17741

When the EU's Covid-19 Vaccine Drive Stumbled, It Turned to Mr. Fixit

 Thierry Breton knew the European Union's vaccine campaign needed help when his boss called him in January.

Covid-19 cases were surging and EU deaths linked to the coronavirus had topped 400,000. The bloc lagged behind weeks behind the U.S. and U.K. in approving vaccines and even further behind in inoculating people. Then Pfizer Inc. and AstraZeneca PLC stunned EU officials by saying deliveries would arrive late.

European Commission President Ursula von der Leyen summoned Mr. Breton to join an emergency videoconference with top pharmaceutical executives and then other calls with German Chancellor Angela Merkel and French President Emmanuel Macron.

Over the previous year, Mr. Breton had become the bloc's Mr. Fixit, spearheading efforts to boost supplies of masks and ventilators when the pandemic first hit. Enlisting him on the vaccine calls meant plans to inoculate the bloc's 450 million people were already stumbling.

"It's the same thing all over again," an aide told Mr. Breton.

Today, hopeful signs are emerging for EU vaccinations, even as case numbers remain high. The bloc is now confident of receiving more than 400 million vaccine doses in the quarter through June, up from 107 million in the first quarter.

Mr. Breton has helped build that confidence through a mix of business savvy and political theatrics that he displayed on Easter Sunday. The former French finance minister and ex-chief executive of multinationals donned a white lab coat, protective glasses and a blue hard hat to tour a French factory making vaccine ingredients.

"I look a bit ridiculous, no?" he said before touring the production hall with its manager. But such visits have allowed Mr. Breton to build a clear picture of the 53 plants across 12 EU countries -- a vital information source that has shaped policy in Brussels and across the bloc.

Europe's vaccine campaign in January had hit a familiar foe of EU crisis-fighting: a lack of centralized control. The bloc's 27 countries had entrusted Brussels with procuring shots for everyone but didn't include the means to keep tabs on their production or hold the pharmaceutical companies accountable. Nobody knew how many vaccines were being made and when they would be delivered. EU countries as a result felt little pressure to accelerate preparations.

Mr. Breton set out on a mission to save the EU's vaccine drive -- and his fellow EU politicians. He dug into vaccine problems just as popular outrage over Europe's slow inoculation drives battered leaders in Brussels and countries including France and Germany.

The 66-year-old Mr. Breton, who has taught at Harvard University and drives to public events in a 20-year-old Volkswagen Beetle, sought to deflect anger and redirect public debate. Flexing political muscle, he publicly berated under-performing vaccine makers, especially AstraZeneca.

"I'm not doing the work of a CEO, I'm doing the work of a politician," said Mr. Breton, in an interview. "You can't send a CEO to do this job -- they'd die."

EU vaccinations are now running about six weeks behind the U.S., relative to population. Europe's initial lack of central coordination contrasts with the U.S., where under Operation Warp Speed the federal government oversaw vaccine development, production and distribution, even tapping military leaders for logistics expertise.

Europeans had relied on their world-leading pharmaceuticals industry, which had led development of many vaccines. Companies had developed and tested shots -- last year considered the biggest hurdle -- so quickly that authorities believed they were home free. But the producers, unprepared for their sudden ramp-up, struggled to deliver on contracts.

"We have underestimated the difficulties inherent in mass production," said Ms. von der Leyen in early February. "Industry has to match the groundbreaking pace of science."

The Breton team's crash course in vaccine production also taught them which companies could boost production fastest and most reliably. Pfizer's January delay, for example, was only temporary -- to add manufacturing capacity. Within weeks, as AstraZeneca continued struggling, Pfizer and partner BioNTech SE were hitting ambitious targets. Their European deliveries rose and accelerated.

Confident in Pfizer-BioNTech's production capacity and the efficacy of their vaccine, the EU recently announced talks to buy up to 1.8 billion more doses next year and in 2023. The duo "has proven to be a reliable partner," Ms. von der Leyen said, in a dig at other suppliers.

Europe's vaccine problems date back a year, to when contract negotiations began. Of six vaccines the EU ordered, none of the first three approved came from a supplier seasoned in mass-producing shots.

BioNTech, a small German firm, had joined with Pfizer to produce its formulation, and while the U.S. company is a global giant, its European production expanded slowly. Boston-based Moderna Inc. also had modest production in Europe, requiring it to tap contract manufacturers to meet output targets.

AstraZeneca had to do the same. Scientists at University of Oxford, who developed the vaccine, in April 2020 selected AstraZeneca as their partner for manufacturing and distribution, but AstraZeneca underestimated the difficulty of delivering the billions of doses they had pledged, according to people familiar with the events.

When AstraZeneca revealed its delays in January, Mr. Breton assembled more than two-dozen staffers, as he had done last spring, assigning some to mapping European vaccine production and others to grasping supply chains for vaccines and related products such as filters and needles. The EU's commissioner for internal markets, Mr. Breton is responsible for ensuring that business functions smoothly across EU countries, which have linked their economies but remain sovereign states.

To untangle incoming information, Mr. Breton arranged video calls directly with drug company chief executives, some over weekends, to get their perspectives and identify bottlenecks. He reminded them he had served as CEO of France Telecom and French tech-consulting firm Atos, earning a reputation as a turnaround specialist.

While most CEOs gave Mr. Breton confidence that they would quickly increase, he said, AstraZeneca CEO Pascal Soriot repeatedly blamed suppliers for production problems that slashed expected deliveries from 120 million to 30 million in the first three months of the year.

"I said, Come on -- I've been a CEO myself. You never give that as an excuse," Mr. Breton recalled saying.

Dr. Soriot hasn't blamed suppliers but pointed to low yields at plants, which have hit European deliveries particularly hard, said a person familiar with the discussions. AstraZeneca tried to close the shortfall by importing doses but faced export curbs, the person said.

Weeks of factory visits, analysis and haggling failed to increase AstraZeneca deliveries. On April 23, the EU sued the company for breach of contract, in an attempt to force deliveries. AstraZeneca said it regretted the commission's decision to take legal action and looked forward to working with it "to vaccinate as many people as possible."

Mr. Breton, by that point, had moved on to helping ensure future production can run more smoothly. That is why at Easter, with most of France observing the holiday or under lockdown, he traveled by train to Dijon to visit a factory making ingredients for Moderna and other pharmaceutical companies.

The plant, owned by Luxembourg-based CordenPharma GmbH, has increased production several hundredfold over recent months and now employs five teams running nonstop.

Arriving on the sunny Sunday morning, Mr. Breton greeted workers like a general reviewing troops. "It's thanks to women and men like you that we will win this fight," he exhorted them.

Inside, CEO Michael Quirmbach explained his rising output and the limits he faces, including a need to send some ingredients to foreign plants -- including in the U.S. -- for purification. A EUR30 million investment, equivalent to $36.3 million, would let the plant handle the task and increase production, while another EUR30 million investment would allow the company to fill vials and finish packaging for more than 100 million extra vaccine doses annually at a plant in Italy, he said.

Mr. Breton told his chief of staff to note the amounts, which the EU could help fund. "This is something very important for us," he said.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/When-the-EU-s-Covid-19-Vaccine-Drive-Stumbled-It-Turned-to-Mr-Fixit-33093636/

Humana 1Q Sales, Profit Results Top Expectations

 Humana Inc. on Wednesday posted revenue and profit growth for the first quarter of 2021 amid improved results from its retail and healthcare-services segments.

The Louisville, Ky.-based health insurer posted earnings of $6.39 a share, up from $3.56 a share in the first quarter of 2020.

On an adjusted basis, Humana's profit was $7.67 a share. Analysts were forecasting an adjusted profit of $7.08 a share, according to FactSet

Humana's revenue climbed to $20.67 billion, from $18.94 billion in last year's first quarter. Analysts had expected revenue of $20.49 billion.

The growth was attributable to strong membership gains in individual Medicare Advantage plans as well as growth in state-based contract membership, the company said. Profitability improved in Humana's group-and-specialty segment, as well as in its healthcare-services segment.

Humana maintained its previously issued adjusted-earnings guidance of $21.25 a share to $21.75 a share for 2021.

https://www.marketscreener.com/quote/stock/HUMANA-INC-13000/news/Humana-1Q-Sales-Profit-Results-Top-Expectations-33092153/