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Monday, May 3, 2021

Regional Health Properties Reports on Fourth Quarter and Full-Year 2020

 Regional Health Properties, Inc. (NYSE American: RHE) (NYSE American: RHEpA), a self-managed healthcare real estate investment company that invests primarily in real estate purposed for senior living and long-term care, reported results for the year ended December 31, 2020.

Business Update

  • Successfully transitioned two non-performing facilities affiliated with one operator, preliminary results for transitioned facilities for January and February 2021 very encouraging

  • Collected 91% of 2020 cash rent

  • Generated positive free cash flow from continuing operations for the fourth quarter and year ended December 31, 2020, despite covid-19 headwinds

Brent Morrison, Regional Health Properties’ Chief Executive Officer and President, commented, "Our portfolio occupancy experienced some softness going into yearend but we remain hopeful that the vaccine rollout and reinstating family visitation privileges should reverse the downward trend by the second half of 2021. 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." Ben Waites, Regional’s Chief Financial Officer added "I’m excited to join the Regional team. 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 (HUD) as well as other capital structure improvements."

https://finance.yahoo.com/news/regional-health-properties-reports-fourth-220300837.html

CVS, Walgreens Wasted More Vaccine Doses Than Most States Combined

 Two national pharmacy chains that the federal government entrusted to inoculate people against covid-19 account for the lion’s share of wasted vaccine doses, according to government data obtained by KHN.

The Centers for Disease Control and Prevention recorded 182,874 wasted doses as of late March, three months into the country’s effort to vaccinate the masses against the coronavirus. Of those, CVS was responsible for nearly half, and Walgreens for 21%, or nearly 128,500 wasted shots combined.

CDC data suggests that the companies have wasted more doses than states, U.S. territories and federal agencies combined. Pfizer’s vaccine, which in December was the first to be deployed and initially required storage at ultracold temperatures, represented nearly 60% of tossed doses.

It’s not completely clear from the CDC data why the two chains wasted so much more vaccine than states and federal agencies. Some critics have pointed to poor planning early in the rollout, when the Trump administration leaned heavily on CVS and Walgreens to vaccinate residents and staff members of long-term care facilities. In response to questions, CVS said “nearly all” of its reported vaccine waste occurred during that effort. Walgreens did not specify how many wasted doses were from the long-term care program.

One thing is clear: Months into the nation’s vaccination drive, the CDC has a limited view of how much vaccine is going to waste, where it’s wasted and who is wasting it, potentially complicating efforts to direct doses to where they are needed most. Public health experts say having a good handle on waste is crucial for detecting problems that could derail progress and risk lives.

The Pfizer-BioNTech and Moderna vaccines, which come in multidose vials, are fragile and have limited shelf lives. Overall, waste has been minuscule: As of March 30, the U.S. had delivered roughly 189.5 million vaccine doses and administered 147.6 million, including 7.7 million in long-term care facilities, according to the CDC.

Among other things, tracking wasted doses helps to identify bottlenecks where distribution adjustments might be needed, said Dr. Bruce Y. Lee, a professor of health policy and management at the City University of New York. Because the federal government is footing the bill for the country’s doses, any waste amounts to “basically throwing [taxpayer] money down the chute,” he said. CVS, Walgreens and other retailers don’t pay for the vaccine. The government provides it. And under the Medicare program, it pays providers roughly $40 for each dose administered.

Particularly early on, officials didn’t adequately assess where there would be demand and set up sites in response, Lee said — something that’s especially important when trying to jab as many people as possible as quickly as possible.

“If you think of any business, they’re going to determine where the customers are first,” he said. “It’s not just a matter of loading up vaccine and going to a place.”

KHN’s survey of vaccine waste is based on public records requests to the CDC and all 50 states, five major cities, Puerto Rico and Washington, D.C. Combined, the records document more than 200,000 wasted doses. However, the data has clear shortcomings. Data from 15 states, the District of Columbia and multiple U.S. territories are not included in the CDC’s records. And, in general, waste reporting has been inconsistent.

In addition to the CDC, 33 states and D.C. provided at least some data to KHN in response to those records requests. They reported at least 18,675 additional doses that have been wasted across 10 jurisdictions not represented in the CDC figures. They include 9,229 doses wasted in Texas as of March 26 and 2,384 in New Hampshire as of March 10.

An additional eight states told KHN of more wasted doses than they reported to the CDC.

But no city or state comes close to the waste reported by CVS and Walgreens, whose long-term care vaccination drive was criticized by some officials as slow and ineffective. Among nursing home staffers, a median of 37.5% reported they got a shot in the first month, according to a February CDC study.

“To me, this ultimately correlates with just poor planning,” said Dr. Michael Wasserman, immediate past president of the California Association of Long Term Care Medicine and a critic of the corporate effort.

Wasserman said the companies’ approach was too restrictive and their unfamiliarity with long-term facilities’ needs harmed the effort.

“CVS and Walgreens didn’t have a clue when it came to interacting with nursing homes,” he said. “Missed opportunities for vaccination in long-term care invariably results in deaths.”

A CVS spokesperson, Michael DeAngelis, in an email blamed wasted doses on “issues with transportation restrictions, limitations on redirecting unused doses, and other factors.”

“Despite the inherent challenges, our teams were able to limit waste to approximately one dose per onsite vaccination clinic,” he added.

Walgreens said its wastage amounted to less than 0.5% of vaccines the company administered through March 29, which totaled 3 million shots in long-term care facilities and 5.2 million more through the federal government’s retail pharmacy partnership.

“Our goal has always been ensuring every dose of vaccine is used,” company spokesperson Kris Lathan said in an email. Before scheduled clinics, she said, Walgreens would base doses it would need on registrations, “which minimized excess and reduced overestimations.”

CDC spokesperson Kate Fowlie said that because the retail pharmacy giants were tasked with administering a large number of doses, “a higher percentage of the overall wastage would not be unexpected, particularly in an early vaccination effort that spanned thousands of locations.” Since President Joe Biden took office in January, his administration has directed pharmacies to prioritize vaccinations for teachers and school personnel.

Overall, pharmacies accounted for almost 75% of wasted doses reported to the CDC. States and some large cities accounted for 23.3% of vaccine waste reported, and federal agencies, including the Bureau of Prisons and the Indian Health Service, for just 1.54%. The Virgin Islands — the only U.S. territory in the federal data — was 0.19%.

“Though every effort is made to reduce the volume of wastage in a vaccination program, sometimes it’s necessary to identify doses as ‘waste’ to ensure anyone wanting a vaccine can receive it, as well as to ensure patient safety and vaccine effectiveness,” Fowlie said. Even still, the CDC has provided guidance and worked with health departments to train staff members to reduce wastage, and clinic staffers should do “everything possible” to avoid wasting shots, she added.

Vaccine waste could increase in the coming weeks as officials shift tactics to inoculate harder-to-reach populations, public health experts say.

I think we are getting to a place where, to continue to be successful with vaccination, we’re going to have to tolerate some waste,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. People unwilling to travel to a mass-vaccination site might go to a primary care physician or smaller rural pharmacy that might not be able to use every dose in an open vial, he said.

Claire Hannan, executive director of the Association of Immunization Managers, said concerns about waste should not trump getting shots into arms.

“If someone’s there, you need to vaccinate them,” she said. “In our efforts not to waste a dose, we may be missing opportunities to vaccinate because we don’t have 15 people lined up or 10 people lined up.”

CDC Numbers Don’t Match State Data

The federal government collects information about vaccine waste through federal systems called VTrckS, which manages ordering and shipments, and Tiberius, a platform run by the Department of Health and Human Services that monitors distribution. VTrckS can exchange data with state and local immunization registries that track who has received a shot, but some states rely on manual data entry, Hannan said.

The 15 states not included in the CDC’s data are Alaska, California, Colorado, Kansas, Louisiana, Maine, Maryland, Michigan, Nebraska, Nevada, New Hampshire, Ohio, Oklahoma, Oregon and Texas. The District of Columbia is also missing.

Of those jurisdictions, 11 provided data to KHN: Alaska, Colorado, Kansas, Maryland, Nebraska, Nevada, New Hampshire, Ohio, Oregon, Texas and D.C.

Most of those reported minimal waste to KHN: Colorado, Kansas, Nebraska and D.C. together registered just 1,090 wasted doses.

In others, the numbers are more significant. On March 19, the Maryland Department of Health said it knew of 3,175 wasted doses.

Texas had the most wasted doses of any state in either the CDC’s data or the data states provided to KHN. Its records showed 9,229 wasted doses as of March 26, putting it third in overall waste behind CVS and Walgreens.

Fowlie, the CDC spokesperson, said the agency is “working closely” with states that have technical issues to ensure accurate reporting.

Broken Freezers, Bent Needles, No-Shows

The reasons states gave for waste varied, from broken vials and syringes, to provider storage errors, to leftover doses from open vials that couldn’t be used.

The largest waste incidents, in which hundreds of doses were lost at a time, tended to be due to freezer malfunctions or workers leaving doses at room temperature too long.

But state records also register the little things that can go wrong.

On Dec. 16, the public health department in Gunnison County, Colorado, lost a single dose of the Pfizer vaccine when someone bumped into a table and a vial spilled. On Jan. 5, the Tri-County Health Department in Westminster, Colorado, reported that it wasted a Moderna dose because a hypodermic needle bent.

Remi Graber is a registered nurse who has vaccinated people at mass sites and community health clinics in Rhode Island. They said it’s not uncommon for a vial to have one too many or one too few doses, which can lead to a dose being counted as wasted. There are also sometimes syringe problems that result in waste.

But Graber said the biggest problem is people not showing up. Once a vial is punctured, Pfizer’s vaccine must be used within six hours. On April 1, Moderna announced that an opened vaccine vial was good for 12 hours — double what it had been previously.

“What could happen is you get people who just decide, ‘You know what? I don’t need my vaccine today. I’m not going to show up,’” they said. “Well, now we’re scrambling to find somebody to take the vaccine, because we don’t want to waste it.”

https://theeagle.com/news/national/cvs-and-walgreens-have-wasted-more-vaccine-doses-than-most-states-combined/article_8400b19a-94ca-5f05-a575-7cd15726f5ca.html

Airport security app Clear looks to score with U.S. ‘vaccine passport’

 Over 60 U.S. stadiums and other venues are deploying an app from Clear to verify people’s COVID-19 status, placing the New York company known for its airport security fast lanes at the forefront of a national debate over “vaccine passports.”

Major League Baseball’s San Francisco Giants and New York Mets are among the first big businesses to demand guests prove they tested negative for the virus or are immunized against it. While the teams welcome paper proof, they encourage downloading records onto Clear’s Health Pass feature for convenience.

As with mask mandates, such requirements are under attack from Republican politicians and anti-surveillance activists, as un-American intrusions on civil liberties. They fear businesses will discriminate against the unvaccinated and unnecessarily amass personal data.

Republican governors including in Florida and Texas last month moved to bar some establishments from asking about immunization status, though legal experts say door-checks are lawful to protect public health.

Privacy group Electronic Frontier Foundation fears Clear and other passport apps will hold data indefinitely and morph into consumer trackers. Clear said users control their health records.

As a business based on replacing physical IDs, tickets and credit cards with facial or fingerprint recognition, Clear has a huge opportunity in emerging health-check rules that would familiarize more people with its technology.

“Those experiences where you have to prove something about you – if we can help empower the consumer to get through that more quickly – that is our core business,” said Catesby Perrin, Clear’s executive vice president of growth.

So far, Clear is among coronavirus health app frontrunners, with partners including United Airlines for its Los Angeles-to-Honolulu flights and the Venetian resort in Las Vegas for conventions it hosts.

With fans anxious to get back to live sports, the Giants said its promotion generated about 6,000 Clear downloads in April. Nationwide, over 70,000 Health Passes are used for venue admission weekly, Clear said, though the app is only starting to verify vaccination status.

(Graphic: U.S. installations of Clear’s app soar as venues reopen: https://graphics.reuters.com/HEALTH-CORONAVIRUS/VACCINE-APP/azgpoxorbvd/chart.png)

Also gaining traction is Excelsior Pass, funded by New York state, which supports verification of tests and vaccinations within the state. The app generated 500,000 certificates in April, and a companion app for businesses to verify them had 40,000 installations, New York spokeswoman Jennifer Givner said.

Excelsior Pass developer IBM Corp is in discussions with additional states, vice president Eric Piscini said.

In Europe, several governments have introduced apps that may be required to access transport, gyms and restaurants, while the 27-nation European Union races to develop a “gateway” that will enable them to work across borders.

Airline-backed Travel Pass and the nonprofit CommonPass, which was installed an estimated 20,000 times over the last two months in the United States, are being tested for international flight checks.

It remains unclear whether high-tech options to prove health status will be widely required. At their best, apps would combat fake records by validating information against public health databases, but that is no small task.

Piscini said it requires accessing at least 64 separate databases in the United States. But California, for example, has yet to specify whether and when it will share records with apps.

Clear has started testing access to vaccination records but declined to disclose details.

New online tools that have gained a few thousand users, including VaxYes and ConfirmD, are attesting to the veracity of vaccine certificate uploads by having medical professionals weed out forgeries.

“The demand (to automate) is there. There’s just a myriad different hoops to get through,” said Mohammad Gaber, chief executive of VaxYes developer GoGet.

AIRPORTS TO BALLPARKS

Clear users upload a driver’s license or other identity document and take a selfie, which the system checks to make sure they match before connecting to COVID-19 test results from hundreds of labs or the proof of vaccination.

Some venues also require a symptom survey on Clear or an automated temperature check at a Clear kiosk.

Users get a “green” pass with their headshot and a QR code to show staff or scan at entrances. Venues pay for the system.

Texas music festival Electric Cookout adopted Health Pass to reduce chances of an outbreak, said co-founder Pooja Shah. About 50 out of 1,200 attendees used it at an April event and received access to special areas, she said.

Clear’s primary service, priced at $179 annually, enables customers to use biometric scans to skip ID card inspections at nearly 40 U.S. airports. It also offers a free service enabling registered users to jet through “Clear lanes” to access entertainment venues.

Combining subscribers and non-paying users, Clear, whose services also go by Alclear and Secure Identity, said it has about 5.7 million members.

The company will not disclose financial results, but announced in February a $100 million funding round with investors including growth firm General Atlantic and the National Football League’s 32 Equity fund.

Clear still has hurdles to become accepted and get people comfortable with using it.

The Seattle Mariners baseball team promoted Clear’s technology for ID-less beer purchases from 2018 through 2019. The team said the effort did not generate “meaningful” usage data.

Washington state’s alcohol regulator said Clear cannot be the “sole methodology for ascertaining legal age.”

Clear said it was pleased with results and continues to educate regulators.

The Giants aim to enable card-less concession sales this year, and its chief business development officer, Jason Pearl, is enthusiastic about Clear’s technology. “I don’t think anyone else comes close.”

https://whbl.com/2021/05/03/airport-security-app-clear-looks-to-score-with-u-s-vaccine-passport/

HCA Sells Four Georgia Hospitals for $950 M

 HCA Healthcare Inc. said Monday it is selling four of its hospitals in Georgia for about $950 million to Piedmont Healthcare, a not-for-profit health system headquartered in Atlanta.

HCA Healthcare said it has agreed to sell the Eastside Medical Center, the Cartersville Medical Center, the Coliseum Health System, and the Coliseum Center for Behavioral Health, a 40 bed inpatient facility.

HCA Healthcare said the transaction provides strategic value by increasing financial flexibility for investments in ongoing and future initiatives in core markets. The company currently operates five other hospitals in the state.

Citigroup is serving as financial advisor to HCA Healthcare. The transaction is expected to close in the third quarter of 2021.

https://www.marketscreener.com/quote/stock/HCA-HEALTHCARE-INC-7534808/news/HCA-Healthcare-Sells-Four-Georgia-Hospitals-for-950-Million-33142080/

Precipio Launches Rapid COVID-19 Antibody test on Amazon Platform

 Nirmidas’ test is available to POC healthcare providers with an Amazon business account

Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced that it has successfully launched its COVID-19 rapid antibody test (20 minute) which tests for both IgG & IgM antibodies, on Amazon.com's business platform. Precipio holds the exclusive rights to distribute this product on Amazon’s platform. The antibody test, which is manufactured in the USA by Nirmidas Biotech, of California, was the first US-based test to receive emergency use authorization (EUA) by the FDA for point-of-care.

The product is visible for sale on Amazon’s website and app (click here), per the EUA approval received for the test kit in December of 2020; however it may currently be purchased only by qualified medical point-of-care (POC) providers. Physicians and other medical facilities may now purchase these items directly from Amazon, and receive them within 2 business days.

https://finance.yahoo.com/news/precipio-launches-rapid-covid-19-133000851.html

CytoDyn May 5 Webcast to Update Multiple Initiatives

 CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman and Chief Medical Officer and Chris Recknor, M.D., Chief Operating Officer will host an investment community webcast on Wednesday, May 5, 2021.

Management will provide a full update to its stockholders on Company priorities, including recent COVID-19 initiatives and additional information concerning its active trials in COVID-19, NASH and cancer.

Management will dedicate approximately 60 minutes to address questions submitted online by analysts and investors.

Date: Wednesday, May 5, 2021
Time: 1:00 pm PT / 4:00 pm ET
Dial-In: None.
Questions:

  • Prior to the webcast, questions can be submitted online to CYDY_Team@cytodyn.com
  • During the webcast, questions can be submitted through the webcast link below.

This is a “listen only” webcast, which can be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software. Please note the below webcast link will not be operational until approximately 60 minutes prior to the start of the webcast, which can be accessed via the following link:

https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/45010/indexl.html

The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until June 5, 2021.

https://www.globenewswire.com/news-release/2021/05/03/2221457/0/en/CytoDyn-to-Hold-Webcast-on-May-5-to-Provide-Update-on-Multiple-Initiatives.html

Sarepta: Positive Clinical Results from Phase 2 Duchenne Study

 

  • Results suggest a highly potent next-generation treatment that could offer greater efficacy with less frequent dosing

  • SRP-5051 dosed monthly at 30 mg/kg delivered mean exon skipping of 10.79% and mean dystrophin expression of 6.55%, consistently higher than the other SRP-5051 dosing cohorts at 12 weeks and weekly eteplirsen at 24 weeks

  • Sarepta’s predictive model indicates that SRP-5051 at 30 mg/kg will achieve greater than 10% dystrophin with monthly chronic dosing

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced positive results from Part A of the MOMENTUM study (Study 5051-201), a global, Phase 2, multi-ascending dose clinical trial of SRP-5051, its next-generation peptide phosphorodiamidate morpholino oligomer (PPMO) treatment for patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.

In biopsies taken at a median of 12 weeks and after only three doses, results from Part A of MOMENTUM study found that the 30 mg/kg of SRP-5051 dosed monthly resulted in 18 times the exon skipping and eight times the dystrophin production as eteplirsen, dosed weekly for 24 weeks. Exon-skipping and dystrophin production in the 30 mg/kg cohort were also consistently higher than the 20 mg/kg cohort of MOMENTUM. Hypomagnesemia was identified in patients taking SRP-5051. Cases have resolved with magnesium supplementation and an analysis of all available data indicate that the hypomagnesemia is monitorable and manageable.

“We are pleased to report strong, dose-dependent exon-skipping and dystrophin expression results with monthly dosing of SRP-5051 – in ambulant and non-ambulant patients. Even at an early timepoint of 12 weeks and after as few as only three doses, these data confirm the potential of Sarepta’s next-generation PPMO platform to be a step order improvement over our current PMO platform, and to profoundly impact the course of Duchenne. While we saw exceptional expression after only a few initial doses, our models predict that we will exceed dystrophin expression levels of 10% of normal or greater over time with SRP-5051,” said Doug Ingram, president and chief executive officer, Sarepta. “We are excited to have chosen our target dose for further development. Part A of MOMENTUM is now complete and Sarepta will work with great urgency to discuss the results with regulatory agencies and gain their insights, including the development path to support an accelerated approval of SRP-5051 in the United States.”