Qelbree (viloxazine extended-release capsules) represents the first novel non-stimulant treatment for ADHD in a decade

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Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD

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MANCHESTER, UK, April 04, 2021 (GLOBE NEWSWIRE) -- As concern around the health risks of alcohol-based sanitiser grows, more hospitals are switching to a safer alternative – HOCL (Hypochlorous Acid), produced by SpectrumX. Hospitals have generally used alcohol-based sanitiser to prevent the spread of disease. But is the end of the line approaching for our go-to disinfectants? With other, better products on the rise, the future of alcohol sanitisers appears more and more sterile. Of course, alcohol-based solutions do their job — they kill pathogens. But they're no longer the safest or most effective option on the market.  Commonly-used alcohol sanitisers can damage skin and trigger dermatitis, eczema, and psoriasis — all of which can be a living nightmare for ever-disinfecting medical staff. They’re also toxic, posing a risk to small children who might drink them.  Just to add fuel to the fire, they’re flammable too — enough to be identified by the NHS as a fire risk when left in hot cars! With these drawbacks becoming more and more well-known, safer alternatives like HOCL are increasingly sought out by medical institutions and commercial clients. Luckily, SpectrumX – an HOCL provider based in the UK – are aiming to step into the breach, with their unique Spectricept solution. Spectricept is completely safe for human use, yet 300 times more effective than bleach at killing pathogens (including bacteria and viruses – yes, even COVID-19).  It’s the only effective formulation of HOCL ever created for use in ‘real world’ conditions —  and SpectrumX holds the license for the UK and Europe. After a year on the frontlines against COVID-19, the prospect of switching to a safer, skin-friendly disinfectant has been warmly welcomed by medical staff. Consultant Surgeon Dr Gordon Buchanan vouches for HOCL:  “My hands are my most important tool for my job. I believe we should be transitioning away from alcohol-based sanitisers in high-use environments.” Dr Gary Davies, Medical Director at Chelsea & Westminster Hospital (where Spectricept is currently used), agrees:  “At the start of the pandemic, hand washing and hand sanitisers suddenly became even more important in the drive of preventing and limiting infection, but I don’t think we necessarily imagined we would be using sanitisers so intensively and for such a long period. Over time we have seen a really significant increase in skin conditions suffered by our staff from high usage of alcohol-based sanitisers. We proactively looked for a safe and effective solution to try to prevent this from happening and have now started utilising an HOCL based product produced by SpectrumX. Feedback from staff members has been overwhelmingly positive."Whilst HOCL has important uses in the current pandemic scenario, it’s future applications have monumental potential effects for post-pandemic life. It’s clear that living in a post-pandemic world means embracing a greater level of sanitation in public  spaces, the workplace and beyond. SpectrumX are currently supporting the Medical University Hospital Innsbruck who are leading a Phase 2 clinical trial for nebulised treatment of COVID-19 patients using SPC-069. SPC-069 is a new class of HOCL-based therapy designed to treat viral bacterial and fungal infections in the lung and respiratory tract. With the benefit of successful trial data, several other potential infection treatment possibilities will be investigated. These include: pneumonia, bronchitis, asthma, flu & the common cold. With advancing  licenses for the only patent-protectable formulation of HOCL in the world, SpectrumX is set to radically alter the way humans treat infectious disease.  SpectrumX is currently raising capital prior to its 2021 listing on the London stock exchange. They intend to become a household name with their array of applications. If you would like to learn more about SpectrumX and how they will revolutionise traditional medicine please click here

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Concerns about alcohol-based sanitisers are changing the way hospitals invest in protecting their staff

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Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell therapy, and the increasing government spend related to these novel techniques, have now caught the eye of federal regulators and prosecutors. In this client alert, we profile some brief context of stem cell therapy, the governments regulations governing these techniques, and some of the best practices for those interested in this emerging space.

Stem cells are cells from which all other cells with specialized functions are generated (i.e., the bodys raw materials). Stem cells may duplicate themselves to create more stem cells or they may generate cells with a specific function like blood or brain cells.

Stem cell therapy is used to repair or replace damaged tissue or cells within the body. Many in the medical community are hopeful that stem cell therapy can be used to treat a wide array of conditions and diseases from multiple sclerosis to vision loss to traumatic spinal cord injuries to Lou Gehrigs disease just to name a few.

The Food and Drug Administration (FDA) oversees and regulates stem cell therapy treatments. While the FDA has acknowledged that stem cell therapy has the potential to treat diseases or conditions for which few treatments exist, there are still only a few treatments that have actually been approved by the FDA. Many treatments are still only in early investigatory stages.

The FDA has recognized the massive potential that stem cell therapy has in allowing patients treatments for various conditions. Consequently, in 2017, the FDA issued guidance indicating its intent to exercise enforcement discretion as a means to support and expedite the development of regenerative medicine products. This enforcement discretion period was to allow innovators time to determine whether to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application as appropriate. The FDA, however, has made clear its enforcement discretion policy only applies to products that do not raise potential significant safety concerns. What the FDA considers significant is debatable, creating uncertainty and ambiguity for those who might be relying on the FDAs enforcement discretion period.

Initially, the FDA stated that its enforcement discretion period would last through November 2020. But in July 2020, the FDA extended its enforcement discretion period through May 2021 a fast-arriving date. It remains unclear whether the FDA intends to extend the time period of its enforcement discretion any further, but either way, stem cell therapy providers would be well-served by planning for and expecting enforcement efforts to ramp up in the near future.

In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy hype, and encouraged consumers to make sure any stem cell therapy treatments were either approved or being studied as an IND. The FDAs concerns have led to multiple enforcement actions, including one just last month. On February 1, 2021, for example, the government announced the indictment of Ashton Derges, a healthcare provider in Missouri, who marketed stem cell shots as a successful treatment for various conditions, including COVID-19. According to the indictment, Derges was paid nearly $200,000 by patients for the stem cell shots, none of which actually contained stem cells at all. While this alleged fraud was not particularly sophisticated, it nonetheless marked a significant development: the governments first criminal prosecution of those touting stem cell therapies.

But blatant fraud is not the only type of stem cell therapy case the government has expressed interest in investigating. A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures. A good case study of the risks associated with aggressive marketing of stem cell therapy is a case out of Florida involving US Stem Cell Clinic Inc. The clinic was marketing stem cell therapy to treat conditions and diseases such as Parkinsons disease, stroke, and brain injuries none of which were approved by the FDA. And, much of the marketing that US Stem Cell Clinic used promised almost miraculous results. As a result, last year, the FDA successfully permanently enjoined the US Stem Cell Clinic from selling or providing those stem cell therapy treatments. Notably, this case was pursued by the FDA despite the FDA explicitly stating its intent to be lenient with emerging stem cell therapy treatments.

Stem cell therapy is a groundbreaking medical tool with great possibilities to treat a plethora of diseases and conditions. As the industry continues to expand, so will the governments interest. Our firm continues to see an uptick in cases involving stem cell therapy treatments. And we have successfully assisted clients in avoiding unnecessary scrutiny by the FDA and other government regulators.

If you are in the stem cell therapy industry or are considering offering stem cell therapy treatments, we recommend that you:

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The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy - JD Supra

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Multiple sclerosis (MS) causes a wide range of symptoms involving the brain, optic nerves, and spinal cord. Research is only just beginning to reveal who is at risk and what causes the condition.

MS is a chronic condition affecting 2.8 million people worldwide. While treatment options are currently limited, trials of several new approaches are underway.

Researchers believe that MS is an autoimmune disorder. This type of illness involves the immune system attacking healthy cells, much as it would attack viruses or bacteria.

In the case of MS, the immune system attacks the myelin sheath that surrounds nerve cells. The attack causes lesions to form, and over time, these cause scarring, which leads to nerve damage and reduced function.

As a result of this damage, a person with MS may experience numbness and tingling sensations, fatigue, muscle weakness, dizziness and vertigo, memory issues, and vision problems, among other symptoms.

There are four types of MS: clinically isolated syndrome (CIS), relapsing-remitting MS, primary progressive MS, and secondary progressive MS.

CIS is a single episode of MS-like symptoms that lasts for at least 24 hours. People with CIS do not necessarily have MS, but experiencing an episode can be the first sign of the condition.

Treating MS involves interdisciplinary care, including rehabilitation, disease-modifying drugs (DMARDs), and complementary and alternative therapies.

Scientists do not fully understand the risk factors for MS and the mechanisms of the condition. However, they are making new headway in the search for answers and improvements in treatment.

What does the latest research show about the risk factors, mechanisms, and treatments of MS? In this Special Feature, Medical News Today takes a closer look.

French neurologist Jean-Martin Charcot first described the features of MS in 1868. He noted the differences between this condition and the tremor of paralysis agitans, a symptom of the neurological condition later named Parkinsons disease.

The three symptoms associated with MS at the time were called Charcots triad. They included a characteristic tremor, involuntary eye movements, also known as nystagmus, and scanning speech, which some call staccato or explosive speech.

Decades later, the invention of MRI scans helped doctors diagnose MS. Treatment with steroids became commonplace, and doctors then began to use medications in a class of drugs called interferons. The Food and Drug Administration (FDA) first approved interferons for use in people with MS in 1993.

Article highlights:

Although scientists and healthcare professionals understand the defining features of MS, several aspects of the condition remain a mystery.

While researchers recognize that MS is an autoimmune condition, they do not understand why immune cells attack myelin.

Also, diagnosing MS is still an ambiguous process because its symptoms are similar to those of many other health conditions.

In addition, experts do not know why women are 23 times more likely to be diagnosed with MS than men.

Research suggests that risk factors of MS include a lack of vitamin D or sunlight, smoking, obesity, a history of infection with the Epstein-Barr virus, being female, and possibly having inherited specific genes, as well as environmental factors.

More recently, the gut microbiota has emerged as a possible risk modulator.

A recent overview of clinical research found that people with MS had larger populations of Pedobacteria, Flavobacterium, Pseudomonas, Mycoplana, Acinetobacter, Eggerthella, Dorea, Blautia, Streptococcus, and Akkermansia bacteria in their intestines than people without MS.

People with MS also had reduced populations of Prevotella, Bacteroides, Parabacteroides, Haemophilus, Sutterella, Adlercreutzia, Coprobacillus, Lactobacillus, Clostridium, Anaerostipes, and Faecalibacterium bacteria.

Researchers speculate that balancing out the populations of gut bacteria in people with MS may reduce inflammation and the overactivation of the immune system.

Research from the MS Society Edinburgh Centre for MS Research found that people with MS had reduced numbers of inhibitory neurons, compared with people who did not have the condition.

However, people with MS had as many stimulating neurons as those without the condition. This was true even for people who had received their MS diagnoses many years earlier.

These findings help reveal the types of neurons affected by MS, shedding more light on how the condition evolves within the body. The research may also offer insight into treatments that could protect the targeted neurons.

DMARDs that health authorities have recently approved as MS treatments include cladribine (Mavenclad) and siponimod (Mayzent) for relapsing-remitting and active secondary progressive forms of the condition.

Cladribine targets lymphocytes, white blood cells responsible for attacks on myelin. Siponimod harnesses specific white blood cells that attack myelin and prevents them from circulating in the body.

However, due to their interactions with the immune system, these drugs may lead to a reduction in lymphocytes, making a person vulnerable to infections.

The medicines actions may also contribute to reduced responses to vaccines in people who receive routine vaccinations. With the introduction of COVID-19 vaccines, scientists have investigated whether people with MS who take medications such as cladribine can have adequate responses to vaccines.

The latest research indicates that people taking cladribine do produce protective antibodies to other common vaccines, despite having decreased lymphocyte levels induced by the medication.

This result gives scientists and others in the medical community hope that people who take these drugs for MS will have similarly adequate responses to COVID-19 vaccines.

Some scientists are currently investigating the potential for stem cell therapy for MS. In a phase 1 study conducted at the Karolinska Institute, in Stockholm, Sweden, seven people with progressive MS received infusions of stem cells derived from each participants own bone marrow.

As early as 7 days after administration of the stem cell therapy, researchers found evidence of positive changes in the participants immune systems. At 12 weeks, five out of six participants had no new characteristic lesions on follow-up MRI brain scans.

As their understanding of the condition evolves, many scientists are investigating the root cause of MS.

An analysis of the current data has revealed a possible connection between gut health and the condition. Data revealing relationships between the gut microbiota and the brain continually emerge, and scientists are hopeful that diet modifications, probiotics, and certain drugs that balance the gut microbiome will play a role in MS treatment.

Also in development are remyelination and neuroprotection therapies. The latter aim to protect the axons and myelin from further damage, while the former could restore lost function for people with MS.

Meanwhile, immunotherapy drugs would protect the nerves from destruction and rebuild neurons that have already sustained damage.

Another potential treatment in phase 1 trials is a tumor necrosis factor-alpha (TNF-alpha) inhibitor called MYMD-1. TNF-alpha is a type of cytokine produced by white blood cells that regulates some aspects of the immune system.

Overproduction of this cytokine is associated with several autoimmune conditions, including MS. MYMD-1 is a new type of TNF-alpha blocker that shows promise as a treatment for MS and other conditions.

Trials for therapies involving the gut microbiome, stem cells, neuroprotective treatments, remyelination, and MYMD-1 are still in the earliest stages. However, the possibilities provide hope that ongoing research will lead to effective ways to prevent MS and better methods of treatment.

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Multiple sclerosis: Recent research on causes and treatments - Medical News Today

Spinal Cord Stem Cells Comments Off on Multiple sclerosis: Recent research on causes and treatments – Medical News Today | April 4th, 2021

The same team of biologists and computer scientists from Tufts University and the University of Vermont that created the Xenobots last year have now developed Xenobots 2.0. Last years version were novel, tiny self-healing biological machines created from frog cells, and they could navigate, push payloads, and act as a collective unit in some cases.

The new Xenobots 2.0 are life forms that can self-assemble a body from single cells. They do not require muscles to move, and they have even demonstrated recordable memory. Compared to their previous counterparts, the new bots move faster, navigate even more environments, and have longer lifespans. At the same time, they can still work together and heal themselves when damaged.

The new research was published in Science Robotics.

With the Xenobots 1.0, the millimeter-sized automations were constructed top down, with the manual placement of tissue and surgical shaping of frog skin and cardiac cells, which produces motion. With the new version of the technology, they were constructed bottom up.

Stem cells were taken from the embryos of the African frog called Xenopus laevis, and this enabled them to self-assemble and grow into spheroids. After a few days, the cells differentiated and produced cilia that moved back and forth or rotated in a specific way.

These cilia provide the new bots with a type of legs that enables them to rapidly travel across surfaces. In the biological world, cilia, or tiny hair-like projections, are often found on mucous surfaces like the lungs. They help by pushing out foreign material and pathogens, but in the Xenobots, they offer rapid locomotion.

Michael Levin is a Distinguished Professor of Biology and director of the Allen Discovery Center at Tufts University. He is the corresponding author of the study.

We are witnessing the remarkable plasticity of cellular collectives, which build a rudimentary new body that is quite distinct from their default in this case, a frog despite having a completely normal genome, said Levin. In a frog embryo, cells cooperate to create a tadpole. Here, removed from that context, we see that cells can re-purpose their genetically encoded hardware, like cilia, for new functions such as locomotion. It is amazing that cells can spontaneously take on new roles and create new body plans and behaviors without long periods of evolutionary selection for those features.

Senior scientist Doug Blackiston was co-first author of the study along with research technician Emma Lederer.

In a way, the Xenobots are constructed much like a traditional robot. Only we use cells and tissues rather than artificial components to build the shape and create predictable behavior. said Blackiston On the biology end, this approach is helping us understand how cells communicate as they interact with one another during development, and how we might better control those interactions.

Over at UVM, the scientists were developing computer simulations that modeled different shapes of the Xenobots, which helped identify any different behaviors that were exhibited in both individuals and groups. The team relied on the Deep Green supercomputer cluster at UVMs Vermont Advanced Computing Core.

Led by computer scientists and robotics expert Josh Bongard, the team came up with hundreds of thousands of environmental conditions through the use of an evolutionary algorithm. The simulations were then used to identify Xenobots that could work together in swarms to gather debris in a field of particles.

We know the task, but its not at all obvious for people what a successful design should look like. Thats where the supercomputer comes in and searches over the space of all possible Xenobot swarms to find the swarm that does the job best, says Bongard. We want Xenobots to do useful work. Right now were giving them simple tasks, but ultimately were aiming for a new kind of living tool that could, for example, clean up microplastics in the ocean or contaminants in soil.

The new version of the bots are faster and more efficient at tasks like garbage collection, and they can now cover large flat surfaces. The new upgrade also includes the ability for the Xenobot to record information.

The most impressive new feature of the technology is the ability for the bots to record memory, which can then be used to modify its actions and behaviors. The newly developed memory function was tested and the proof of concept demonstrated that it could be extended in the future to detect and record light, the presence of radioactive contamination, chemical pollutants, and more.

When we bring in more capabilities to the bots, we can use the computer simulations to design them with more complex behaviors and the ability to carry out more elaborate tasks, said Bongard. We could potentially design them not only to report conditions in their environment but also to modify and repair conditions in their environment.

The new version of the robots are also able to self-heal very efficiently, demonstrating that they are capable of closing the majority of a severe full-length laceration half their thickness within just five minutes.

The new Xenobots carry over the ability to survive up to ten days on embryonic energy stores, and their tasks can be carried out with no additional energy sources. If they are kept in various different nutrients, they can continue at full speed for months.

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Xenobots 2.0 are Here and Still Developed With Frog Stem Cells - Unite.AI

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Scientists have created small, synthetic living machines that self-organize from single cells, move quickly through different environments without the need for muscle cells, can remember their experiences, heal themselves when damaged, and exhibit herd behaviors.

Earlier, scientists have developed swarms of robots from synthetic materials and moving biological systems from muscle cells grown on precisely shaped scaffolds. But until now the creation of a self-directed living machine has remained beyond reach.

Biologists and computer scientists from Tufts University and the University of Vermont have created novel, tiny self-healing living machines from frog cells (Xenopus laevis) that they call Xenobots. These can move around, push a payload, and even exhibit collective behavior in a swarm.

In an article titled A cellular platform for the development of synthetic living machinespublished in the journal Science Robotics, the researchers report a method for creating these of Xenobots from frog cells. This cellular platform can be used to study self-organization, collective behavior, and bioengineering and provide versatile, soft-body, living machines for applications in biomedicine and environmental biology.

The next version of Xenobots have been createdtheyre faster, live longer, and can now record information [Doug Blackiston, Tufts University]

We are witnessing the remarkable plasticity of cellular collectives, which build a rudimentary new body that is quite distinct from their defaultin this case, a frog despite having a completely normal genome, says Michael Levin, Distinguished Professor of Biology and director of the Allen Discovery Center at Tufts University, and corresponding author of the study. In a frog embryo, cells cooperate to create a tadpole. Here, removed from that context, we see that cells can re-purpose their genetically encoded hardware, like cilia, for new functions such as locomotion. It is amazing that cells can spontaneously take on new roles and create new body plans and behaviors without long periods of evolutionary selection for those features.

Xenobots can move around in a coordinated manner with the help of cilia present on their surface. These cilia grow through normal tissue patterning and do not require complicated architectural procedures such as scaffolding or microprinting, making the high-throughput production of Xenobots possible. And while the frog cells are organizing themselves into Xenobots, they are amenable to surgical, genetic, chemical, and optical stimulation. The researchers show that the Xenobots can maneuver through water, heal after damage and exhibit predictable collective behaviors.

The scientists also provide a proof of principle for a programmable molecular memory using a light-controlled protein that can record exposure to a specific wavelength of light.

Compared to their first edition, Xenobots 1.0, that were millimeter-sized automatons constructed in a top down approach by manual placement of tissue and surgical shaping of frog skin and cardiac cells to produce motion, this updated version of Xenobots 2.0 takes a bottom up approach. The biologists took stem cells from frog embryos and allowed them to self-assemble and grow into spheroids, where some of the cells after a few days differentiated to produce ciliatiny hair-like projections that move back and forth or rotate in a specific way. Cilia act like legs to help the new spheroidal Xenobots move rapidly across a surface.

In a way, the Xenobots are constructed much like a traditional robot. Only we use cells and tissues rather than artificial components to build the shape and create predictable behavior. Says Doug Blackiston, PhD, senior scientist and co-first author on the study with research technician, Emma Lederer. On the biology end, this approach is helping us understand how cells communicate as they interact with one another during development, and how we might better control those interactions.

Scientists at UVM ran computer simulations that modeled different shapes of the Xenobots and analyzed its effects on individual and collective behavior. Robotics expert, Joshua Bongard, PhD, and a team of computer scientists used an evolutionary algorithm on the Deep Green supercomputer cluster at UVMs Vermont Advanced Computing Core to simulate the behavior of the xenobots under numerous random environmental conditions. These simulations identified Xenobots that excelled at working together in swarms to gather large piles of debris in a field of particles.

We know the task, but its not at all obviousfor peoplewhat a successful design should look like. That is where the supercomputer comes in and searches over the space of all possible Xenobot swarms to find the swarm that does the job best, says Bongard. We want Xenobots to do useful work. Right now, were giving them simple tasks, but ultimately were aiming for a new kind of living tool that could, for example, clean up microplastics in the ocean or contaminants in soil.

Xenobots can quickly collect garbage working together in a swarm to sweep through a petri dish and gather larger piles of iron oxide particles. They can also cover large flat surfaces and travel through narrow capillaries.

The Tufts scientists engineered the Xenobots with a memory capability to record one bit of information, using a fluorescent reporter protein called EosFP that glows green but when exposed to blue light at 390nm wavelength, the protein emits red light instead.

The researchers injected the cells of the frog embryos with messenger RNA coding for the EosFP protein before the stem cells were excised to create the Xenobots so that the mature Xenobots have a built-in fluorescent switch which can record exposure to blue light.

To test the memory capacity, the investigators, allowed 10 Xenobots to swim around a surface on which one spot is illuminated with a beam of blue light. After two hours, they found that three bots emitted red light. The rest remained their original green, effectively recording the travel experience of the bots. This molecular memory in Xenobots could be harnessed to detect the presence of radioactive contamination, chemical pollutants, drugs, or a disease condition.

When we bring in more capabilities to the bots, we can use the computer simulations to design them with more complex behaviors and the ability to carry out more elaborate tasks, said Bongard. We could potentially design them not only to report conditions in their environment but also to modify and repair conditions in their environment.

The biological materials we are using have many features we would like to someday implement in the botscells can act like sensors, motors for movement, communication and computation networks, and recording devices to store information, says Levin. One thing the Xenobots and future versions of biological bots can do that their metal and plastic counterparts have difficulty doing is constructing their own body plan as the cells grow and mature, and then repairing and restoring themselves if they become damaged. Healing is a natural feature of living organisms, and it is preserved in Xenobot biology.

Cells in a biological robot can also absorb and break down chemicals and work like tiny factories, synthesizing and excreting chemicals and proteins.

Xenobots were designed to exhibit swarm activity, moving about on cilia legs. [Doug Blackiston, Tufts University]

Originally posted here:
Scientists Create Living Machines That Move, Heal, Remember and Work in Groups - Genetic Engineering & Biotechnology News

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ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics, Inc. (AgeX; NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported its financial and operating results for the fourth quarter and the full year ended December 31, 2020.

Recent Highlights

Liquidity and Capital Resources

Amendment to 2019 Loan Agreement

On February 10, 2021, AgeX entered into an amendment to its 2019 Loan Facility Agreement with Juvenescence Limited (Juvenescence). The Amendment extends the maturity date of loans under the agreement to February 14, 2022 and increases the amount of the loan facility by $4.0 million. All loans in excess of the initial $2.0 million that AgeX previously borrowed are subject to Juvenescences discretion.

At-the-market Offering Facility

During January 2021 AgeX entered into a sales agreement with Chardan Capital Markets LLC (Chardan) for the sale of shares of AgeX common stock in at-the-market (ATM) transactions. In accordance with the terms of the sales agreement, AgeX may offer and sell shares of common stock having an aggregate offering price of up to $12.6 million through Chardan acting as the sales agent. Through March 26, 2021, AgeX raised approximately $496,000 in gross proceeds through the sale of shares of common stock.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, AgeX believes that its cash and cash equivalents and available sources of debt and equity capital would not be sufficient to satisfy AgeXs anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Annual Report on Form 10-K for the year ended December 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

Balance Sheet Information

Cash, and cash equivalents, and restricted cash totaled $0.6 million as of December 31, 2020, as compared with $2.5 million as of December 31, 2019. Since January 1, 2021, AgeX had cash proceeds of approximately $3.2 million through loans from Juvenescence, sales of shares of AgeX common stock, and the disposition of its subsidiary LifeMap Sciences, Inc. (LifeMap Sciences) through a cash-out merger.

Fourth Quarter and Annual 2020 Operating Results

Revenues: Total Revenues for the fourth quarter of 2020 were $0.5 million. Total revenues for the year ended December 31, 2020 were $1.9 million, as compared with $1.7 million in the same period in 2019. AgeX revenue was primarily generated by its subsidiary LifeMap Sciences, Inc. which AgeX disposed of on March 15, 2021 through a cash-out merger. Revenues for the year ended December 31, 2020 also included approximately $0.3 million of allowable expenses under a research grant from the NIH as compared with $0.2 million in the same period in 2019.

Operating expenses: Operating expenses for the three months ended December 31, 2020, were $2.9 million, as reported, which was comprised of $2.5 million for AgeX and $0.4 million for LifeMap Sciences, and were $2.3 million, as adjusted, comprised of $2.0 million for AgeX and $0.3 million for LifeMap Sciences.

Operating expenses for the full year 2020 were $12.4 million, as reported, which was comprised of $10.4 million for AgeX and $2.0 million for LifeMap Sciences, and were $10.2 million, as adjusted, comprised of $8.7 million for AgeX and $1.5 million for LifeMap Sciences.

Research and development expenses for the year ended December 31, 2020 decreased by $0.9 million to $5.0 million from $5.9 million in 2019. The decrease was primarily attributable to the layoff of research and development personnel in May 2020.

General and administrative expenses for the year ended December 31, 2020 decreased by $0.7 million to $7.4 million from $8.1 million in 2019. Increases in personnel costs related to an increase in administrative staffing were offset to some extent by a decrease in noncash stock-based compensation expense, general office expense and supplies and travel related expenses with the shelter in place mandates since March 15, 2020 resulting from the COVID-19 pandemic, and the elimination of shared facilities and services fees from AgeXs former parent Lineage Cell Therapeutics, Inc. following the termination of a Shared Facilities and Services Agreement on September 30, 2019.

The reconciliation between operating expenses determined in accordance with accounting principles generally accepted in the United States (GAAP) and operating expenses, as adjusted, a non-GAAP measure, is provided in the financial tables included at the end of this press release.

Other expense, net: Net other expense for the year ended December 31, 2020 was $0.5 million, as compared with net other income of $0.3 million in the same period in 2019. The change is primarily attributable to increased amortization of deferred debt costs to interest expense following the consummation of loan agreements.

Net loss attributable to AgeX: The net loss attributable to AgeX for the year ended December 31, 2020 was $10.9 million, or ($0.29) per share (basic and diluted) compared to $12.2 million, or ($0.33) per share (basic and diluted), for the same period in 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeXs PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. HyStem is AgeXs delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands, except par value amounts)

December 31,

2020

2019

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

527

$

2,352

Accounts and grants receivable, net

326

363

Prepaid expenses and other current assets

1,430

1,339

Total current assets

2,283

4,054

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The pancreas, saysGary Lewis, an endocrinologist at Toronto General Hospital and director of the Banting & Best Diabetes Centre at the University of Torontos Temerty Faculty of Medicine, is like an exquisitely sensitive and perfectly networked computer.

Second by second,he notes,the pancreassecretesjust the right amount ofinsulinor glucagontolower or raiseblood sugarintotheportal veinthat leadsdirectlyto the liver, the site of key metabolic processes. Insulingis then distributedto every tissue in the body via general circulation.

Thats one reason a cure for diabetes has proven elusive 100 years after the discovery of insulin.

Another big reason is the complexity of how the disease arises. In type 1 diabetes, the immune system destroys the insulin-producing beta cells of the pancreas, creating a life-threatening spike in blood sugar. Type 2 diabetes usually comes on more slowly, as the body becomes resistant to insulin or the pancreas cant produce enough of it.

Genetics play a role in both types. Exposure to viruses and other environmental effects may be a factor in type 1. Lifestyle factors, including weight gain and physical inactivity, are strongly linked to type 2.

The bottom line, says Lewis, is that diabetes is a multifactoral disease, and were not close to a cure.

Ask about treatments, though, and Lewis gets excited.

The last two decades have brought a plethora of clinical and research advances, from new drugs to boost and sensitize the body to insulin and promote weight loss, to lifestyle interventions that improve diet, continuous monitoring of blood sugar, long- and short-lasting insulin, better insulin pumps, pancreatic transplantsand pre-clinical stem cell and immunosuppressive therapies.

Progress on treatments has been fantastic, especially for type 2, Lewis says. Im very, very hopeful.

The distinction between treatment and cure in medicine is often unclear. And for the 3.6 million Canadians living with diabetes, the distinction matters less and lessif the goal is a full and healthy life.

Type 2 diabetes accounts for about 90 per cent of diabetes cases in Canada. Prevalence is rising, but Canadians with type 2 diabetes are living longer and have fewer diabetes-related complications.

The clinic doesnt look like it did 30 years ago, says Lewis, who mainly treats patients with type 2. We see fewer amputees, less blindness. Patients are generally healthier, and their prognosis is often excellent if they maintain their blood sugar target and other key parameters.

Weight loss is a cornerstone of treatments to lower blood sugar, and recent research has strengthened the link between weight reduction and type 2 diabetes management. Some people with type 2 can lose weight and control blood sugar through dietary changes and exercise alone.

Bariatric surgery is very effective for weight loss and often results in diabetes remission, although it comes with surgical risks and is expensive.

If we could prevent obesity, we could greatly reduce the incidence of type 2, Lewis says. And experiments have shown wecan get a remission withlifestyle changes, so we know what works.

The problem is broad implementation.

Ive tried to lose weight and I know how difficult it can be, especially in an environment of convenient and inexpensive calories, Lewis says. Moreover, factors such as income, education, ethnicity, access to healthy food and living conditions can make lifestyle changes that curb obesity nearly impossible.

Social determinants of health are overwhelmingly the most important influence on who gets type 2 diabetes, and how well or poorly they do with it, Lewis says.

Fortunately, dozens of new drugs for diabetes have hit the market in the last two decades.

Medications for weight loss round out the armamentarium, and some also protect against kidney damage and lower cardiac risk. Current therapies can reduce body weight up to 10 per cent, although a loss of 20 per cent or more would have a greater effect on outcomes for patients with type 2 diabetes, saysJacqueline Beaudry, an assistant professor of nutritional sciences at U of T who studies links between obesity, hormones and diet.

Beaudry is probing the biology that underpins these medications, including the gut hormones GLP-1 and GIP. They control blood glucose and reduce appetite, but scientists are unsure how.

If we could understand their mechanisms of action, we could design better drugs, Beaudry says.

For people with type 1 diabetes, continuous glucose monitors, insulin pumps and even automated closed-loopsystems that run on mobile apps to deliver insulin as-needed have radically changed the patient experience.

Sara Vasconcelos left),an assistant professor at U of Ts Institute of Biomedical Engineering, has worked withCristina Nostro (right), an associate professor in the department of physiology,and her team in the McEwen Stem Cell Institute at UHNto extend the survival and functionality of pancreatic precursor cells generatedfrom human stem cells.

Cell therapy could prove more liberating still.

University labs and biotechs are working on implantable devices that house insulin-producing cells derived from stem cells.

To that end,Cristina Nostro, an associate professor in the department of physiology in the Temerty Faculty of Medicine,and her team in the McEwen Stem Cell Institute at University Health Network recently discovered a more efficient way to generate and purify pancreatic precursor cells from human stem cells in the lab.

They have also found a way to vascularize those cells by working withSara Vasconcelos, an assistant professor at U of Ts Institute of Biomedical Engineering. Together, they have extended the survival and functionality of the cells in animal models of diabetes.

The biggest problem with these therapies is that the immune system rejects them. The same challenge currently hinders pancreas and islet transplants.

The immune system is an amazing machine, were luckyits so good, says Nostro. But its very difficult to control when it goes awry, as in autoimmune conditions.

Nostro is working with immunologists at the university on a method to protect insulin-producing beta cells from immune rejection, and she says many researchers in the field are now focused on immune-protective approaches.

Another strategy for type 1 diabetes is to tamp down the autoimmune response before the disease progresses. The idea is to prevent immune cells that damage the pancreas while the body still produces beta cells.

Groups around the world are bringing different ideas and creative approaches to treat type 1 diabetes, thats the beauty of science, says Nostro. I am very hopeful about what the future holds. Who knows? Maybe we will see hybrid technologies combining a pump and cells. We have to keep an open mind.

This story was originally published in U of T Med Magazines Insulin Issue.

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BASKING RIDGE, N.J., March 08, 2021 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, today announced that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to the Company’s CD34+ cell therapy product, CLBS12, for the treatment of Buerger’s disease – also known as thromboangiitis obliterans – a condition related to critical limb ischemia (“CLI”) with no approved treatments to date in the U.S. .

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PRESS RELEASE

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Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic Obesity

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Dr. Paul Walker will remain on the Board of Directors focusing on the seamless transition of management and on ensuring continuity of the Tigris Trial

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EMERYVILLE, Calif., March 08, 2021 (GLOBE NEWSWIRE) -- Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer and infectious disease immunotherapies, today announced two promotions within its leadership team. Karin Jooss, Ph.D., previously the company’s executive vice president of research and chief scientific officer, has been appointed to the position of head of research and development. Erin Jones, M.S., who served as the company’s executive vice president of global regulatory affairs and quality, has been appointed to the position of chief operating officer (COO).

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SOUTH SAN FRANCISCO, Calif., March 08, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company delivered a presentation on its SARS-CoV-2 3CLpro inhibitor candidate, ALG-097111, at the 28th Conference on Retroviruses and Opportunistic Infections, being held virtually March 6 to March 10, 2021, during the meeting’s Science Spotlight sessions on Saturday, March 6. Aligos performed all research in collaboration with Belgian University KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), and the Rega Institute for Medical Research.

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SAN DIEGO, March 08, 2021 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and utilizing a product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced today the appointment of Lisa Johnson-Pratt, M.D., Senior Vice President, New Product Planning at Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), to its Board of Directors.

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TORONTO, March 08, 2021 (GLOBE NEWSWIRE) -- Silo Wellness Inc. (“Silo Wellness” or “the Company”) (CSE: SILO), a wellness company in the psychedelics and functional mushroom marketplaces, is pleased to announce that on Saturday, March 6, Silo launched its second ketamine-assisted psychedelic wellness retreat on the iconic McKenzie River in Oregon and third psychedelic retreat in 2021.

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CARLSBAD, Calif., March 08, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today that Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen, will present at the Oppenheimer 31st Annual Healthcare Conference being held March 16-18 2021.

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TORONTO, CHICAGO and MONTREAL, March 08, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) announced today that Ken d’Entremont, Chief Executive Officer, and Roland Boivin, Chief Financial Officer of Medexus, will be conducting 1x1 meetings with investors during the 33rd Annual Roth Conference being held virtually from March 15th – March 17th, 2021.

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AUSTIN, Texas, March 08, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company developing product candidates for Alzheimer’s disease, has been invited to present at the H.C. Wainwright Global Life Sciences Conference, a virtual event being held Tuesday, March 9th, and Wednesday, March 10th, 2021. Management is scheduled to present and will participate in virtual one-on-one meetings with institutional analysts and investors throughout the conference.

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San Diego, Calif., March 08, 2021 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (OTCQB: SKYE) (“SKYE” or the “Company”), a biopharmaceutical company focused on developing proprietary, synthetic cannabinoid-derived molecules to treat glaucoma and other diseases with significant unmet need, announced today the appointment of scientific innovators and cannabinoid experts, Giovanni Appendino, PhD and Eduardo Muñoz, MD, PhD to its scientific advisory board.

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LA JOLLA, Calif, March 08, 2021 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company” or “INmune”), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, today announced that its management team is scheduled to participate in two upcoming virtual investor conferences in March 2021.

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