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CytoDyn Inc (OTCMKTS: CYDY) Breaking Out Northbound as Biotech Hires New President, Raises $21.8 million & Sets Shareholders Meeting for August 31

CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold…

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CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold on the Company’s HIV program and a full clinical hold on its COVID-19 program in the United States. CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share and Microcapdaily covered the stock regularly back in those exciting times. Since than CYDY has been downward bound, first suffering from the Citron short attack and more recently the March 30 drop after the FDA hold. Further, CytoDyn elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission. CYDY saw further declines after the Company’s CEO and registered public accounting firm, Warren Averett LLC, both resigned. All of this has culminated in CYDY being offered at a cheap discount to prices from just a few months ago and the opportunity to buy in to Cytodyn for under $0.50 per share.  

CYDY has been busy in recent weeks completing a stock offering during which the Company was able to raise $21.8 million. They also signed on a new President; Cyrus Arman, Ph.D. who previously held positions with a number of biotech’s most recently serving as Chief Business Officer of Nimble Therapeutics, Inc., a company focused on engineering peptides. Also on August 31, there is a special meeting of stockholders to vote on a proposal to amend the total number of authorized shares of common stock from 1,000,000,000 shares to 1,350,000,000 shares. While moral may be low among shareholders at the moment the Company has once again avoided bankruptcy and ensured its existence for a while longer during which time anything is likely to happen. CYDY is a stock trading under $0.50 that ran to $10 per share in 2020 with a similar share structure. The underlying science of Leronmilab has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, and HIV.  Considering how fast CYDY dropped the bounce potential here is significant and CYDY could make rapid gains in a very shorty time period.  

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CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions. 

CytoDyn believes in the future of precision medicine… more specificity, less side effects. The Company’s target, the CCR5 receptor, has been implicated in multiple disease processes from HIV, GvHD, NASH, stroke recovery, multiple sclerosis, COVID-19, NAFLD/NASH, to metastatic cancer. Leronlimab, our CCR5 antagonist, is a once-a-week, subcutaneous injection. One molecule with multiple opportunities. Welcome to the future of target specific, precision medicine. Welcome to CytoDyn, a biotechnology company focused on developing innovative treatments for multiple therapeutic indications. The Company’s lead candidate leronlimab (PRO 140) belongs to a new class of therapeutics called viral-entry inhibitors and is an experimental monoclonal antibody for HIV treatment. 

Microcapdaily first covered CYDY on February 1, 2020 when the stock was $1.50 as it was on its way to $10 per share in summer 2020 reporting at the time: “CYDY is an exciting company in small caps developing a promising drug in the billion-dollar HIV market. Just last week CYDY announced an $87.5 million licensing deal for commercializing Leronlimab to treat HIV. The stock is in full beast mode currently among the top most traded stocks in small caps. CYDY Is still pre revenue and high risk with a very exciting week.” 

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CYDY

Cytodyn saw a significant drop on March 30 after the Company reported the US FDA placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the United States. Further, the Company elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission. This was followed by a Company webcast the very next day. The stock saw further declines after the Company’s registered public accounting firm, Warren Averett, LLC resigned, released in an 8k on April 19 

On April 12 CYDY announced the publication of a peer-reviewed research paper entitled “Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species” in the open-access journal PLOS Pathogens. The study followed five HIV+ human participants who, after successfully transitioning to once weekly subcutaneous leronlimab, halted their previous daily oral antiretroviral therapy regimens. These five participants came from an extension study, consisting of patients who were virologically suppressed in a prior study of leronlimab. Of the ten patients enrolled in the extension study, four individuals experienced viral rebound and stopped leronlimab monotherapy, and one individual withdrew, leaving five long-term participants. All five long-term participants successfully maintained HIV suppression via leronlimab monotherapy for over seven years, with no evidence of viral escape. It is important to note that these five participants on leronlimab monotherapy exhibited a higher frequency (7.1%) of transient episodes of plasma viremia, termed viral blips, than those on combinational oral antiretroviral regimens (2.0%). To monitor the anatomical penetrance of leronlimab, rhesus macaques acutely infected with simian human immunodeficiency virus (SHIV) were treated with high intravenous doses of leronlimab for 12 weeks. Leronlimab treatment reduced SHIV viral loads by 10,000 fold and leronlimab was found within all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency, respectively.

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Currently trading at a $336 million market valuation CYDY has 717,854,997 shares outstanding, CYDY is fully reporting OTCQB and while they are pre revenues the Company has close to $100 million in assets and about the same in debt. At current levels CYDY is worth a close look; The stock was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share. The underlying science has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, HIV and coronavirus.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. CYDY has been busy in recent weeks completing a stock offering during which the Company was able to raise $21.8 million. They also signed on a new President; Cyrus Arman, Ph.D. who previously held positions with a number of biotech’s most recently serving as Chief Business Officer of Nimble Therapeutics, Inc., a company focused on engineering peptides. Also on August 31, there is a special meeting of stockholders to vote on a proposal to amend the total number of authorized shares of common stock from 1,000,000,000 shares to 1,350,000,000 shares. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.

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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.

The post CytoDyn Inc (OTCMKTS: CYDY) Breaking Out Northbound as Biotech Hires New President, Raises $21.8 million & Sets Shareholders Meeting for August 31 first appeared on Micro Cap Daily.

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Nonprofit Blood Donation Service Starts Matching Unvaccinated Patients With Donors

Nonprofit Blood Donation Service Starts Matching Unvaccinated Patients With Donors

Authored by Allan Stein via The Epoch Times (emphasis ours),

Swiss…

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Nonprofit Blood Donation Service Starts Matching Unvaccinated Patients With Donors

Authored by Allan Stein via The Epoch Times (emphasis ours),

Swiss naturopathic physician George Della Pietra believes people worldwide should be free to choose whether to get a COVID-19 vaccine injection or not.

He believes the same should hold for those receiving transfusions with “vaccinated” blood.

“The problem is right now we have no choice,” said Della Pietra, founder of the nonprofit Safe Blood Donation service in 2021, matching unvaccinated blood recipients with donors in 65 countries.

“It was very clear from the beginning that the COVID hype was way out of control,” Della Pietra said. “It was not as dangerous as they say it was.

“As a naturopath, I can make no sense of this pandemic, which was never really a pandemic. It leaves space for so many explanations.”

Della Pietra believes that an mRNA injection is more dangerous than the pharmaceutical companies are willing to admit. He said the growing numbers of adverse reactions are reason to question their safety and effectiveness.

Data from the Centers for Disease Control and Prevention (CDC) showed that vaccinated and boosted people made up 58.6 percent (6,512) of the COVID-19 deaths in August—up from 41 percent in January.

We can no longer say this is a pandemic of the unvaccinated,” Cynthia Cox, the Vice President of the Kaiser Family Foundation told The Washington Post in an article on Nov. 23.

Nearly 70 percent of the world’s 8 billion people have received at least one mRNA injection for COVID-19 since the vaccines began rolling out in 2021 at the height of the virus’s spread.

Each of the three primary mRNA COVID-19 vaccines contains COVID-19 “spike protein” fragments, which bind at the cellular level to stimulate an immune response to the virus.

Della Pietra believes these spike proteins produce “classic symptoms”—namely blood clots—that “horrified” him.

“I’ve never seen anything similar—and I’m not talking only about spike proteins,” Della Pietra told The Epoch Times in a phone interview.

It’s unbelievable because we never had this problem before. It’s been only two years. They want to keep the narrative [that an mRNA vaccine] is not dangerous.”

A man looks at his phone while donating blood at Vitalant blood donation center in San Francisco on Jan. 11, 2022. (Justin Sullivan/Getty Images)

Although donated blood and plasma must undergo a cleansing process before transfusion, Safe Blood Donation says this is not enough to remove all mRNA ingredients.

“I’m talking about graphene oxide and non-declared inorganic components in the vaccine, which we can see in the blood. When I see them, I have no idea how we can get rid of them again,” Della Pietra said.

Looking at the abnormalities in vaccinated blood, he said, “OK, we have a problem.” People are receiving the vaccine “more or less through the back door.”

“You can not avoid it anymore.”

In the United States alone, there are approximately 16 million units of donated blood annually. Of those units, about 643,000 are “autologous”—self-donated—and the number is increasing yearly, according to BloodBook.com.

Della Pietra said that, to his knowledge, Safe Blood Donation, based in Switzerland, is the first unvaccinated blood donation service of its kind.

“So, there is no blood bank with mRNA-free blood yet, not even with us,” Safe Blood Donation states on its website.

“And, although we have already asked hundreds of clinics, at the moment—at least in Europe—all of them still refuse to allow the human right of free blood choice with them—or at least do not want to be mentioned because otherwise, they fear reprisals.”

A nurse works as employees donate blood during a blood drive held in a bloodmobile in Los Angeles on March 19, 2020. (Mario Tama/Getty Images)

Della Pietra said the main goal of Safe Blood Donation is not to start an mRNA-free blood bank. Rather, it is to make it possible to match unvaccinated blood donors and unvaccinated recipients, “which we bring together in a clinic (medical partner) that allows the choice of blood donor.”

Medical website Seed Scientific said that blood banks and biotech companies will offer as much as $1,000 monthly for blood donations.

While Della Pietra said there are no unvaccinated blood banks, he sees the demand for unvaccinated blood rising.

This is why I decided to do [SafeBlood Donation]. I wanted to make a network for unvaccinated people looking for a blood donor because they need it—whether they have scheduled surgery or an emergency,” he said.

Safe Blood Donation began working in the United States about a month ago, building an infrastructure of medical partners.

However, in the current medical environment, central blood banks such as the Red Cross do not segregate their blood donations based on their vaccinated or unvaccinated status.

Rendering of SARS-CoV-2 spike proteins binding to ACE2 receptors. (Shutterstock)

“The American Red Cross does not facilitate designated donations for standard blood needs, as this process often takes longer and is more resource intensive than obtaining a blood product through our normal process,” the Red Cross told The Epoch Times in an email.

In a small number of situations, there is an exception for rare blood types where compatible blood types are extremely difficult to find. A rare blood type is defined as one that is present in less than 1/1000 people.

“We want to emphasize that the Red Cross adheres to all donor and product requirements as determined by the FDA to ensure the safety of the blood supply and is committed to continuing to provide life-saving blood products for patients across the country.”

The National Library of Medicine said that “across study sites, the average hospital cost per unit transfused was $155 and the average charge per patient was $219.”

Still, the Red Cross, which provides 40 percent of the nation’s blood donations, said “no studies” demonstrate adverse outcomes from transfusions of blood products collected from vaccinated donors.

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Tyler Durden Sun, 12/04/2022 - 20:55

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Pedestrians choose healthy obstacles over boring pavements, study finds

Up to 78% of walkers would take a more challenging route featuring obstacles such as balancing beams, steppingstones and high steps, research has found….

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Up to 78% of walkers would take a more challenging route featuring obstacles such as balancing beams, steppingstones and high steps, research has found. The findings suggest that providing ‘Active Landscape’ routes in urban areas could help tackle an “inactivity pandemic” and improve health outcomes.

Credit: Anna Boldina

Up to 78% of walkers would take a more challenging route featuring obstacles such as balancing beams, steppingstones and high steps, research has found. The findings suggest that providing ‘Active Landscape’ routes in urban areas could help tackle an “inactivity pandemic” and improve health outcomes.

[A copy of the paper and images can be downloaded here]

Millions of people in the UK are failing to meet recommended targets for physical activity. Exercising “on the go” is key to changing this but while walking along a pavement is better than nothing it causes no significant increase in heart rate so only qualifies as mild exercise. Walking also fails to significantly improve balance or bone density, unless it includes jumping, balancing, and stepping down.

But would adults opt for such ‘fun’ routes if given the choice? A University of Cambridge-led study published today in the journal Landscape Research suggests that with the right design, most would.

Previous research on ‘healthy route choices’ has focused on people’s likelihood of walking instead of using transport. But this study examined how likely people are to pick a more challenging route over a conventional one and which design characteristics influenced their choices.

Lead author, Anna Boldina, from the University of Cambridge’s Department of Architecture, said: “Even when the increase in level and extent of activity level is modest, when millions of people are using cityscapes every day, those differences can have a major positive impact on public health.”

“Our findings show that pedestrians can be nudged into a wider range of physical activities through minor changes to the urban landscape. We want to help policy makers and designers to make modifications that will improve physical health and wellbeing.”

Boldina began this research after moving from Coimbra in Portugal – where she found herself climbing hills and ancient walls – to London, which she found far less physically challenging.

Working with Dr Paul Hanel from the Department of Psychology at the University of Essex, and Prof. Koen Steemers from Cambridge, Boldina invited almost 600 UK residents to compare photorealistic images of challenging routes – variously incorporating steppingstones, balancing beams, and high steps – with conventional pavements.

Participants were shown images of challenging and conventional tarmac routes and asked which route they would choose. The researchers tested out a range of encouraging / discouraging parameters in different scenarios, including crossing water, shortcuts, unusual sculptures and the presence / absence of a handrail and other people. Participants were asked to score how challenging they thought the route would be from 1 (as easy as walking on level tarmac) to 7 (I would not be able to do it).

Eighty per cent of the study’s participants opted for a challenging route in at least one of the scenarios, depending on perceived level of difficulty and design characteristics. Where a challenging option was shorter than a conventional route, this increased the likelihood of being chosen by 10%. The presence of handrails achieved a 12% rise.

Importance for health

The WHO and NHS recommend at least 150 minutes of ‘moderate’ or 75 minutes of ‘vigorous’ activity spread over a week, including a variety of activities aimed at enhancing bones, muscles, and agility to stay healthy. In addition, adults over 65 are advised to perform strength, flexibility, and balance exercises.

Boldina said: “The human body is a very complex machine that needs a lot of things to keep working effectively. Cycling and swimming are great for your heart and for your leg muscles but do very little for your bone density.”

“To improve cardiovascular health, bone density and balance all at once, we need to add a wider range of exercises into our routine daily walks.”

Psychology of choice

Co-author Dr Paul Hanel said: “Children don’t need much encouragement to try out a balance beam but we wanted to see how adults would respond, and then identify design modifications which made them more likely to choose a challenging route.”

“We found that while embarrassment, anxiety, caution and peer pressure can put some adults off, the vast majority of people can be persuaded to take a more challenging route by paying careful attention to design, safety, difficulty level, location and signage.”

The proportion of participants who were willing to pick a more challenging route varied from 14% for a particular balance beam route to 78% for a route involving wide, low stepping stones and a log with a handrail. The least intimidating routes were found to be those with wide, steady-looking balancing beams and wide steppingstones, especially with the presence of handrails.

The researchers suggest that routes that incorporate more difficult challenges, such as obstacle courses and narrow balancing beams, should be placed in areas more likely to be frequented by younger users.

The participants expressed a range of reasons for picking challenging routes. Unsurprisingly, the study found that challenging routes which also acted as short cuts appealed. Up to 55% of participants chose such routes. The researchers also found that the design of pavements, lighting and flowerbeds, as well as signage helped to nudge participants to choose more challenging routes. Many participants (40%) said the sight of other people taking a challenging route encouraged them to do the same.

The participants who picked conventional routes often had concerns about safety but the introduction of safety measures, such as handrails, increased uptake of some routes. Handrails next to one steppingstones route increased uptake by 12%.

To test whether tendency to choose challenging routes was linked to demographic and personality factors, participants were asked to answer questions about their age, gender, habits, health, occupation, and personality traits (such as sensation seeking or general anxiety).

The researchers found that people of all levels of activity are equally likely to pick a challenging route. But for the most difficult routes, participants who regularly engaged in strength and balancing exercises were more likely to choose them.

Older participants were as supportive of the concept as younger ones but were less likely to opt for the more challenging routes for themselves. Nevertheless, across all age groups, only a small percentage of participants said they would avoid adventurous options completely.

The study applies the idea of “Choice Architecture” (making good choices easier and less beneficial choices harder) plus “Fun theory”, a strategy whereby physical activity is made more exciting; as well as some of the key principles of persuasion: social proof, liking, authority, and consistency.

Future work

The researchers hope to run experiments in physical test sites to see how intentions convert into behaviour, and to measure how changes in habits improve health. In the meantime, Dr Boldina continues to present her findings to policy makers.

Critics might question the affordability and cost effectiveness of introducing ‘Active landscape routes’ in the current economic environment.

In response, the researchers argue that installing stepping stones in a turfed area can be cheaper than laying and maintaining conventional tarmac pavements. They also point out that these measures could save governments far greater sums by reducing demand for health care related to lack of exercise.

Reference

A. Boldina et al., ‘Active Landscape and Choice Architecture: Encouraging the use of challenging city routes for fitness’, Landscape Research (2022). DOI: 10.1080/01426397.2022.2142204

Media contact

Tom Almeroth-Williams, Communications Manager (Research), University of Cambridge: researchcommunications@admin.cam.ac.uk / tel: +44 (0) 7540 139 444


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Apple Accelerates Plans To Shift Production Out Of China

Apple Accelerates Plans To Shift Production Out Of China

Apple has accelerated plans to shift some of its production outside of China, the…

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Apple Accelerates Plans To Shift Production Out Of China

Apple has accelerated plans to shift some of its production outside of China, the Wall Street Journal reports, citing insiders.

The company has been reportedly telling suppliers to 'actively' plan on assembling Apple products elsewhere in Asia - primarily India and Vietnam, as the company looks to reduce dependence on Taiwanese assemblers spearheaded by Foxconn.

The company's goal is to ship 40-45% of iPhones from India, vs the current single-digit percentage, according to TF International Securities analyst, Ming-chi Kuo. Vietnam is also expected to shoulder more of the manufacturing of other Apple products, such as AirPods, smartwatches and laptops.

A worker is shown disinfecting equipment.

The decision was sparked by turmoil at "iPhone City" inside Zhengzhou (a 'city-within-a-city'), where as many as 300,000 workers assemble iPhones and other Apple products as a Foxconn-run factory, which produces roughly 85% of the iPhone Pro lineup, according to Counterpoint Research.

In November, violent protests hit the Zhengzhou factory - as workers upset over wages and Covid-19 restrictions began rioting and throwing things at the police. All of this poses a risk to Apple, which has relied on the factory as a stable manufacturing center.

Zhengzhou is home to a giant Foxconn facility known as iPhone City, where a worker is shown at right disinfecting equipment. (Shang Ji/Future Publishing/Getty Images)

"Apple no longer feels comfortable having so much of its business tied up in one place," according to the report.

So no, Apple isn't moving production out of concerns over human rights abuses, censorship, or other types of oppression.

"In the past, people didn’t pay attention to concentration risks," said former US-based Foxconn executive, Alan Yeung. "Free trade was the norm and things were very predictable. Now we’ve entered a new world."

One response, say the people involved in Apple’s supply chain, is to draw from a bigger pool of assemblers—even if those companies are themselves based in China. Two Chinese companies that are in line to get more Apple business, they say, are Luxshare Precision Industry Co. and Wingtech Technology Co. 

On calls with investors earlier this year, Luxshare executives said some consumer-electronics clients, which they didn’t name, were worried about Chinese supply-chain snafus caused by Covid-19 prevention measures, power shortages and other issues. They said these clients wanted Luxshare to help them do more work outside China. -WSJ

The concerns over production revolve around new product introduction (NPI), which requires teams to work with contractors to translate blueprints and prototypes into a detailed manufacturing plan. According to the report, Apple has put its manufacturing partners on notice to start trying to do more of this outside of China.

That said, unless places like Vietnam and India can excel at NPI as well, they will 'remain stuck playing second fiddle' according to supply chain specialists.

For now, consumers doing Christmas shopping are stuck with some of the longest wait times for high-end iPhones in the product’s 15-year history, stretching until after Christmas. Apple issued a rare midquarter warning in November that shipments of the Pro models would be hurt by Covid-19 restrictions at the Zhengzhou facility. -WSJ

The shift marks a massive change in the relationship between Apple and China - which for decades have been engaged in a mutually beneficial relationship.

According to Kup, the supply-chain analyst, iPhone shipments in the fourth quarter of this year were likely to reach between 70 and 75 million units - around 10 million fewer than market projections before the Zhengzhou riots.

"Apple is going to have to find multiple places to replace iPhone City," said Dan Panzica, a former Foxconn executive who now advises companies on supply-chain issues. "They’re going to have to spread it around and make more villages instead of big cities."

Tyler Durden Sun, 12/04/2022 - 13:55

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