Thanyapura, StemCells21 to offer premium stem cell treatments in Thailand – BSA bureau

The partnership will offer premium stem cell treatments for various degenerative diseases, immune disorders, injuries and anti-ageing.

Thanyapura Sports and Health Resort, Phuket has partnered with StemCells21 (SC21), a medical biotech company based in Bangkok, Thailand. With over a decade of clinical history and 100 years of collective team experience, SC21 combines 21stcentury cellular medicine and cutting-edge supportive therapies to offer the highest quality stem cell treatments with Mesenchymal Stem Cells (MSCs) and Induced Pluripotent Stem Cells (iPSCs).

A first of its kind for Phuket, Thanyapura in partnership with SC21, will offer premium stem cell treatments for various degenerative diseases, immune disorders, injuries and anti-ageing. The treatments can also tackle a host of medical problems such as type 2 diabetes, osteoarthritis, chronic back pain and inflammatory lung diseases such as asthma and bronchitis, as well as strengthen body immunity and improve fertility.

In the sporting world, regenerative medicine is seen as a crucial component and can aid in optimising the human body to perform at a higher level, as well as being highly effective in the treatment of sports injuries through faster healing, reduced injury inflammation and the regeneration of injured tissue. The human-based regenerative therapy has been successful with high calibre athletes for endurance enhancement and lengthening professional careers by reducing injury rates.

Guests can book a free dedicated one-on-one consultation with a certified stem cell specialist for their first session. Those seeking longer-term treatments can book a discounted stay at Thanyapura to utilise its world-class facilities, award-winning vegan and vegetarian restaurants and lifestyle clinic.Team isexcited to facilitate their first clinic outside of Bangkok.

President & CEO of Thanyapura World, Philipp Graf von Hardenberg said, "Treatment packages can be customised from the number of Premium Grade (P1) MSCs to the treatment duration and include supportive therapies from a comprehensive health check-up to the highest standards of after-care services. Thanyapuras 360 approach will help in delivering better, longer-lasting outcomes for challenging conditions that conventional therapies often fail to address, such as stopping disease progression, as well as avoiding surgical intervention.

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BioRestorative Therapies Emerges from Chapter 11 Reorganization – OrthoSpineNews

MELVILLE, N.Y., Nov. 20, 2020 (GLOBE NEWSWIRE) BioRestorative Therapies, Inc. (BioRestorative or the Company) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, announced today that its amended joint plan of reorganization has become effective and it has emerged from Chapter 11 reorganization. Pursuant to the confirmed plan of reorganization, the Company has received $3,848,000 in financing. The confirmed plan of reorganization also provides for additional funding, subject to certain conditions, of $3,500,000 less the sum of the debtor-in-possession financing provided to the Company during the reorganization (approximately $1,227,000) and the costs incurred by the debtor-in-possession lender.

In connection with the reorganization, Lance Alstodt has been appointed the Companys President, Chief Executive Officer and Chairman of the Board. Mr. Alstodt said, This process has been a long and challenging journey for the Company. Im inspired by the great resolve and execution from our employees, professionals and investors. We are very pleased that all requirements have been met for us to emerge. Allowed creditor claims have been fully satisfied and, as importantly, our equity holders have retained their shares in this exciting new opportunity. We were able to preserve all of our intellectual property assets and look forward to initiating our Phase 2 clinical trial.

Based upon the Companys emergence from Chapter 11 reorganization, FINRA has removed the Q at the end of its trading symbol. Shareholders do not need to exchange their shares for new shares.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate,BRTX-100,is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. TheBRTX-100production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure,BRTX-100is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial usingBRTX-100to treat persistent lower back pain due to painful degenerative discs.

Metabolic Program (ThermoStem): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release containsforward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Companys latest Form 10-K filedwith the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email: ir@biorestorative.com

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Look back at pharma news in the week to November 20, 2020 – The Pharma Letter

Clinical trial results featured in last weeks news, some good and others not so good. Cytokinetics

To continue reading The Pharma Letter please login,subscribeorclaim a 7 dayfree trial subscriptionand access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space.

Or, if you're only interested in reading the content about a specific topic (M&A, coronavirus/COVID-19, pricing, reimbursement and access, outsourcing, CRO and CMO, and regulation), then you can take our 10 per month channel subscription offer, which gives you access to all our news articles and in-depth content on this subject.

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BioRestorative Therapies Emerges from Chapter 11 Reorganization Other OTC:BRTX – GlobeNewswire

MELVILLE, N.Y., Nov. 20, 2020 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (BioRestorative or the Company) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, announced today that its amended joint plan of reorganization has become effective and it has emerged from Chapter 11 reorganization. Pursuant to the confirmed plan of reorganization, the Company has received $3,848,000 in financing. The confirmed plan of reorganization also provides for additional funding, subject to certain conditions, of $3,500,000 less the sum of the debtor-in-possession financing provided to the Company during the reorganization (approximately $1,227,000) and the costs incurred by the debtor-in-possession lender.

In connection with the reorganization, Lance Alstodt has been appointed the Companys President, Chief Executive Officer and Chairman of the Board. Mr. Alstodt said, This process has been a long and challenging journey for the Company. Im inspired by the great resolve and execution from our employees, professionals and investors. We are very pleased that all requirements have been met for us to emerge. Allowed creditor claims have been fully satisfied and, as importantly, our equity holders have retained their shares in this exciting new opportunity. We were able to preserve all of our intellectual property assets and look forward to initiating our Phase 2 clinical trial.

Based upon the Companys emergence from Chapter 11 reorganization, FINRA has removed the Q at the end of its trading symbol. Shareholders do not need to exchange their shares for new shares.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

Metabolic Program (ThermoStem): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email: ir@biorestorative.com

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Novartis bags Mesoblast’s stem cell therapy for ARDS, including in Covid-19, in a deal worth up to $1.2B+ – Endpoints News

Novartis has licensed a new stem cell therapy from Mesoblast, just weeks after the FDA rejected the Australian biotechs pitch for an approval on a separate indication.

The Swiss pharma announced Thursday afternoon it is partnering with Mesoblast $MESO to develop remestemcel-L for the treatment of acute respiratory distress syndrome, including ARDS related to Covid-19. As part of the deal, Novartis will shell out $25 million in upfront cash and take a $25 million stake in the biotech, while offering up to $1.255 billion in potential milestone payments.

Mesoblast investors embraced the news, sending shares up 11% on the Australian stock exchange Friday. The companys stock was also up roughly 17% on the Nasdaq before Fridays opening bell.

The milestone payments are split as such, per Mesoblast: $505 million will be available pre-commercialization, with an additional $750 million set aside for hitting certain sales targets and double-digit royalties.

Remestemcel-L, or Ryoncil, acts as an anti-inflammatory and consists of culture-expanded mesenchymal stem cells derived from a bone marrow donor. Currently, the drug is being evaluated in a Phase III study for Covid-19-related ARDS with 300 patients, and the first cut of data is expected in early 2021.

Should that outcome prove successful, Novartis will launch a Phase III in non-Covid ARDS after the deal closes. The companies highlighted Novartis ability to rapidly scale up cell-based therapies from the clinic to the commercial phase as a motivator for the collaboration.

The drug had been examined in a small compassionate use program for Covid-19 ARDS back in March, which included 12 patients requiring ventilators. Remestemcel-L treatment demonstrated an 83% survival rate in that program and was the basis for the ongoing Phase III.

Thursdays deal comes less than two months after the FDA issued a CRL for remestemcel-L in Mesoblasts pediatric acute graft-versus-host disease program. The rejection, which denied the company an accelerated approval, came after an ODAC adcomm in August voted 9 to 1 in favor of approval as panel members struggled to envision what a pivotal trial might look like.

During both the adcomm and in their CRL, regulators took issue with Mesoblasts study design given that the company submitted its application on the basis of one, single-arm and open-label trial. In the study, Remestemcel-L demonstrated a statistically significant benefit in its primary endpoint against the historical control rate.

But because many parents and pediatricians are reluctant to risk putting children into the placebo arm of a randomized study, Mesoblast argued that key opinion leaders said an additional study was not feasible. The veto came despite the FDA approving a similar drug Incyte and Novartis Jakafi based on one single-arm trial, something for which ODAC members chastised the FDA.

Earlier this week, Mesoblast met with the agency for its Type A meeting, and the company reported in its third quarter earnings that it does not expect the FDA to reverse its decision for accelerated approval. Mesoblast is still waiting to receive final meeting minutes to know whether thats indeed the case. The CRL set back potential approval in GvHD from 2021 to 2024, per analysts.

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Ruxolitinib for Acute Graft-vs-Host Disease Improves Outcomes in the Second Line – Targeted Oncology

During a Targeted Oncology Case Based Peer Perspective event, Usama Gergis, MD, MBA, professor of Oncology, director, Bone Marrow Transplant and Immune Cellular Therapy at Sidney Kimmel Cancer Center, at the Thomas Jefferson University Hospital, discussed the case of a 48-year-old male patient with acute graft-versus-host-disease (GVHD).

Targeted Oncology: For a patient such as this, what is the risk of developing acute (GVHD) following transplant?

GERGIS: The list of risk factors for GVHD is huge: donor HLA [human leukocyte antigen] disparities that are major/minor, sex matching, donor parity, donor age, blood typewhile its controversialdonor CMV seropositivity, gene polymorphism, and stemcell graft source. Obviously, peripheral mobilized stem cells have more T cells than bone marrow. Other factors include graft composition, the higher CD34 the higher lymphocytes, and conditioning intensities. There are a bunch of factors here, at least for our patient, who had a MAC. The fact that his donor is a multirisk, 50-year-old woman and a MUD [infers] similar higher risk.

How quickly do you determine whether a patient is steroid refractory or steroid dependent?

Basically, steroid refractoriness or resistance versus dependence versus intolerance [can be determined in] as early as 3 days. If there is progression of the grade of GVHD, this is considered steroid refractory. If by 4 weeks it does not go to grade 0, its considered refractory. However, I disagree with the 28-day [timeline]. I think its a long time to wait. Usually, I look at 2 weeks.

This has been the consensus among many of us. I think the trials REACH-1 [NCT02953678] and REACH-2 [NCT02435433] looked at 28 days; but if you go to the 2 papers, most responses took place in 7 to 14 days. Again, this is in the second-line setting.

Ive been doing this for 15 years. Ive been through most of this; so many lines [of therapy and] so many heartbreaks. I teach my fellows to look at any [research] paper in second-line GVHDthe overall response rate is 30%. Ive done it with MMF [mycophenolate mofetil], sirolimus [Rapamune], infliximab [Remicade], ATG [antithymocyte globulin], cyclophosphamide, Ontak [denileukin diftitox], and mesenchymal stem cells and overall response rate is 30%.

Which data support the use of ruxolitinib (Jakafi) in patients who are steroid refractory?

Based on a small trial of 49 patients, a phase 2 trial [INCB 18424-271; NCT02953678], ruxolitinib was approved as a second-line therapy for patients with acute steroid-refractory GVHD.1

Review the details of the REACH-2 trial.

The REACH-2 trial data were just published in 2020. Ruxolitinib was approved based on a small trial of 49 patients with steroid-refractory acute GVHD. They enrolled 70 but only 49 were available for efficacy. Obviously, it was a pilot phase 2 with no comparative arm, and the response rates across the board were [somewhere in the range of] 50% or so by day 28.

Then they were asked to run a phase 3 trial comparing ruxolitinib at 10 mg twice daily versus best available care. The best available care goes through the list that I just mentioned, including photopheresis, ATG, and others. After 4 weeks, patients who were not responders on the best available care were allowed to cross over to ruxolitinib.

By day 28, the responders on the ruxolitinib composed 60% of the cohort versus 40% on the control arm with a P value of less than .001. The durability of response at 8 weeks was 40% versus 20% [odds ratio, 2.38; 95% CI, 1.43 to 3.94; P < .001].

This tell us that ruxolitinib works in this group, that it does not work that great in one-third of patients who lose their response at 8 weeks, and that its just better than anything else [thats available]. A good thing about the ruxolitinib arm is that the response duration was much longer than best available treatment, as illustrated by the Kaplan-Meier curve for response duration.

Failure-free survival [in this trial] was 5.0 months versus 1.0 month [HR, 0.46; 95% CI, 0.35-0.60].

Do you apply this therapy to any of your patients?

We have a patient [at my institution] who has steroid-refractory GVHD. Last Friday in our weekly meeting, we were discussing his [case]. He has lower GI [gastrointestinal] GVHDgrade IV, steroid-refractory, as bad as it getsand I said lets start him on ruxolitinib. One of my colleagues said it doesnt work well in the lower GI. I asked the organizers to pull [data] from the supplemental figures on the New England Journal of Medicine paper of REACH-2 [indicating that these patients did have a benefit with ruxolitinib].2

REFERENCES:

1. FDA approves ruxolitinib for acute graft-versus-host disease. FDA. May 24, 2019. Accessed October 10, 2020. https://bit.ly/2SMU7I8

2. Zeiser R, von Bubnoff N, Butler J, et al; REACH2 Trial Group. Ruxolitinib for glucocorticoid- refractory acute graft-versus-host disease. N Engl J Med. 2020;382(19):1800-1810. doi: 10.1056/NEJMoa1917635

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AgeX Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update – BioSpace

Nov. 16, 2020 21:05 UTC

ALAMEDA, Calif.--(BUSINESS WIRE)-- AgeX Therapeutics, Inc.. (AgeX; NYSE American: AGE), a biotechnology company developing innovative regenerative therapeutics to treat human diseases to increase healthspan and combat the effects of aging, reported financial and operating results for the third quarter ended September 30, 2020.

Q3 Highlights

This quarter, we continued to build upon our licensing and collaboration model through our new agreement with ImStem that provides us an avenue for participating financially in potential treatments for COVID-19 and acute respiratory distress syndrome or ARDS. Since the first of the year, AgeX has entered into six agreements that could lead to the development of new cell therapies by our licensees and collaborators, which utilize our core technologies and cell lines with potential future income streams to AgeX, said Greg Bailey M.D., Chairman of AgeX. In addition, expansion of our agreement related to ESI clinical-grade pluripotent stem cell lines will now allow us independence to build ESI cell lines as a to-go-to source for deriving cell based therapeutics across the industry.

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the New Loan Agreement) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. As of November 16, 2020, AgeX has borrowed $5.5 million and may draw additional funds from time to time subject to Juvenescences discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1.0 million in any single draw. More information about the New Loan Agreement can be found in AgeXs Annual Report on Form 10-K and Quarterly Reports on Form 10-Q for the periods ended March 31, 2020, June 30, 2020, and September 30, 2020 filed with the Securities and Exchange Commission on March 30, 2020, May 14, 2020, August 14, 2020, and November 16, 2020, respectively.

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, and considering that loans from Juvenescence under the New Loan Agreement will be subject to Juvenescences discretion, AgeX believes that its cash and cash equivalents, the remaining $2.5 million available under the New Loan Agreement and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

Third Quarter 2020 Operating Results

Revenues: Total revenues for the third quarter of 2020 were $434,000 as compared with $411,000 for the third quarter of 2019. AgeX revenues are primarily generated from subscription and advertising revenues from the GeneCards online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $40,000 of allowable expenses under AgeXs research grant from the NIH. Revenues from that grant were $41,000 in the same period in 2019.

Operating expenses: Operating expenses for the three months ended September 30, 2020 were $2.8 million as compared to $3.6 million for the same period in 2019. Operating expenses are comprised of research and development expense and general and administrative expenses. On an as-adjusted basis, operating expenses for the three months ended September 30, 2020 were $2.3 million as compared to $3.0 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses were $0.8 million during the three months ended September 30, 2020, a $0.6 million decrease from $1.4 million during the same period in 2019. The decrease was primarily attributable to the layoff of 11 research and development personnel in May 2020 and the elimination of shared services payments to Lineage Cell Therapeutics, Inc. (Lineage) with the termination of our Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses decreased by $0.3 million to $1.9 million during the three months ended September 30, 2020 from $2.2 million during the same period in 2019 despite an increase in head count resulting from the employment of AgeXs own finance team commencing in October 1, 2019. These increases were offset by a decrease in noncash stock-based compensation expense, travel and 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 Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 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 and Quarterly Reports on Form 10-Q 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

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

September 30,2020

December 31,2019

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

1,107

$

2,352

Accounts and grants receivable, net

241

363

Prepaid expenses and other current assets

581

1,339

Total current assets

1,929

4,054

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How regenerative medicine could be used to contain COVID-19, others – Guardian

*Practice provides answer to challenges conventional medicine deemed unfixable, say expertsMore studies are validating the use of regenerative medicine to restore damaged organs, restore acute stroke patients, heal chronic pain and erectile dysfunction in male and female as well as prevent and treat viral infections such as COVID-19.

Indeed, several studies have shown that regenerative medicine is uniquely positioned to provide advanced organoid models to understand the infection mechanism of, identify patients at risk for, and develop ways to prevent COVID-19, as well as to introduce innovative treatments that have immune-modulatory and regenerative properties.

Organoids are tiny, self-organised three-dimensional tissue cultures that are derived from stem cells. Such cultures can be crafted to replicate much of the complexity of an organ, or to express selected aspects of it like producing only certain types of cells.

According to a recent study published in the journal Stem Cell Reviews and Reports and titled Regenerative Medicine in COVID-19 Treatment: Real Opportunities and Range of Promises, studies are increasing to find the best therapeutic approach for COVID-19 and its management.

The researchers said regenerative medicine offers various cell-tissue therapeutics and related products, such as stem cell therapy, natural killer (NK) cell therapy, Chimeric antigen receptor (CAR) T cell therapy, exosomes, and tissue products. Interestingly, mesenchymal stem cells (MSCs) can reduce inflammatory symptoms and protect against cytokine storm, which critically contributes to the COVID-19 progression, they said.

The researchers concluded: COVID-19 can involve multiple systems, including the central nervous system, the gastrointestinal system, and the respiratory system, and this will depend on its profound effects on the immune system. Regenerative medicine offers various cell-tissue therapeutics and related products that might help the reversal of COVID-19-related immune dysregulation. In particular, the promising features of MSCs, including their regenerative properties and ability to differentiate into diverse cell lineages, have generated considerable interest among researchers whose work has offered intriguing perspectives on cell-based therapies for various diseases.

The immune-modulatory effects of MSCs, which may assist in inhibiting cytokine storm and lung inflammation, are of particular interest for COVID-19 therapy. Finally, Induced pluripotent stem cells (iPSCs) can help the development of a personalised approach to COVID-19 therapy.

iPSCs are useful for researchers as they can provide an inexhaustible supply of cells that are identical to the patients.

A United States (U.S.) Board Certified Internist with a strong passion for regenerative aesthetic and cosmetic medicine, and Medical Director of Glory Wellness & Regenerative Centre, Ikeja, Lagos, Dr. David Ikudayisi, told The Guardian: One of the regenerative medicine protocols, which we also have available at our Centre, was approved for COVID-19 purposes; leveraging its immune modulatory effect to calm the potentially fatal cytokine storm of the disease. It also has the benefit of preventing or limiting lung scarring. Another protocol is in the early phase of clinical trial. While we are not a COVID-19 treating centre, it is important to note that regenerative medicine can play a role in the reduction of many of the adverse effects caused by COVID-19.

Ikudayisi said the future of regenerative medicine is very bright. We believe that the future of regenerative medicine is inevitable, and that conventional medicine will only have to catch up as it usually does to new discoveries in medicine. The more people get to hear about the merits and see the evidence; it will not be long before it becomes the norm. It starts with everyday people and medical professionals doing their due diligence and doing their research as I did. My team and I are always available to answer questions about it, and we welcome it on all our social platforms as well. We really hope it catches up soon enough to maximise these great benefits for many more patients in dire need of these amazing solutions.

Regenerative medicine has continued to generate excitement. What makes it significantly different from conventional medicine, and why would you recommend it for anyone in need of treatment? Ikudayisi said: It is great to see that Nigeria is catching up with the possibilities of regenerative medicine for our health. Conventional medicine uses anything from conservative management, the use of medication, or surgery at the other extreme to help maintain good health or get us as close to it as possible.

He said regenerative medicine on the other hand leverages the bodys natural healing mechanisms and attempts to accentuate their effects by increasing their availability to the specific organs needing regeneration. The ability to harness the bodys natural healing mechanisms using adult stem cell therapy (a subcategory of regenerative medicine) while minimising adverse effects confers on regenerative medicine a considerably greater safety profile than conventional medicine, Ikudayisi said.

He said regenerative medicine is not the secret sauce to fix all health problems, but is, however, a great tool provided by modern medicine to provide an answer to many health challenges that conventional medicine had deemed unfixable. Ikudayisi said conditions that have been considered incurable by conventional medicine due to their degenerative effects, are now made curable in the practical sense as regenerative medicine takes care of the organ degeneration.

The physician said the scientific/physiological base of the therapeutic effects of regenerative medicine, specifically adult stem cell therapy, creates endless opportunities for its application. Think about it this way, if the medical condition is of a degenerative nature, then regenerative medicine can be a viable option, he said.

Ikudayisi said he would continue to recommend regenerative medicine to anyone in need of treatment because where conventional medicine fails; it offers hope and delivers results beyond what conventional medicine can offer in most cases. The benefits are even more noticeable in acute phases of degeneration, he said.

Can regenerative medicine treat only select ailments or all manner of sicknesses? Ikudayisi said: The scope of application is broad and multi-systemic. This means it can be used for various systems and functions in the body. While the exceptions are diseases of a non-degenerative nature such as genetic or chromosome-related diseases; nonetheless, people with these challenges can see a reduction or improvement in symptoms even though it is not cured. Healthy people use it for anti-agEing, to feel stronger and healthier as well as look younger as they age.

As I mentioned earlier, regenerative medicine is not here to replace other branches of medicine. Like other new innovations in medicine, it can add value to other forms of medicine. For example, a patient with a displaced fracture needs the intervention of an orthopedic surgeon not regenerative medicine. However, it can be added during or after the orthopedic surgery to accelerate the healing process.

Here at Glory Wellness & Regenerative Centre in Lagos, Nigeria, we have seen so many success stories with this branch of medicine. We have treated patients with complex quadriplegia (two years old injury before our involvement due to partial transection of cervical spinal cord) and another with over nine years with cerebral palsy, both of whom have now gained the ability to move some of their extremities independently. We have also seen patients with uncontrolled diabetes with hypertension who now have blood pressures and hemoglobin A1c levels within the normal range as a result of these treatments.

We have also seen great results in patients treated for female/male sexual dysfunction, pain in their joints, neck, and back, and acute stroke (especially when the acute stroke is treated very early to prevent permanent residual symptoms). All patients with autoimmune disorders can also benefit from regenerative medicine; however, they will need continued treatments to maintain the symptoms relief.

Autistic patients in Nigeria are also benefiting from it, especially if the cause is autoimmune related (since up to 25 per cent of the autistic spectrum disorder could be caused by autoimmune diseases). Patients with chronic kidney disease in the early stages are not left out, but they will need more than one treatment session. This is just to mention a few medical conditions. One of the many joys we get is talking to people about their ailments and seeing how regenerative medicine can play a role in rejuvenating their health.

What feedback are you getting from those who have accessed this branch of medicine?Ikudayisi said many of the patients treated at Centre are delighted at their results, so much so that they are spreading the word person to person. We get a great number of them who are so pleasantly surprised of the outcome, as they also see improvements in areas they did not even think to mention to us. It is noteworthy that the therapeutic benefits they have received from regenerative medicine had been practically impossible with conventional medicine hence their satisfaction, joy, and excitement, he said.

The physician said an example is the case of a man with left testicular atrophy and low testosterone. After one session of autologous treatment, the left testicle grew back to normal size and the production of testosterone significantly increased. People who have infertility issues, both male and female, should not give up without considering one of the regenerative medicine protocols, especially those women that have tried In Vitro Fertilisation (IVF) without success, he said.

How affordable is this new branch of medicine? It is truly relatively expensive due to the demand on medical manpower and the present cost of required materials. However, the costs are gradually coming down which we hope is sustained and accelerated so that more people can benefit. Our goal is to get these treatments to as many people as possible. This involves finding ways to reduce cost without compromising on value. Whenever possible, we notify our patients of these price cuts. Furthermore, there are alternative options of treatment with varying costs: this makes these treatments ultimately accessible to more people. The latest biggest price reduction is for people with pain in their peripheral joints, female and male sexual dysfunction, female urinary incontinence, chronic non-healing wounds, facial acne, and uneven skin tone.

I would like to mention that middle class to low income patients in Nigeria have also benefited from some of our regenerative medicine protocols.

Regardless of the cost of the procedure, you cannot put a price tag on a human life. Human life is priceless. As the famous adage goes, Your health, your wealth.

What is the success rate of regenerative medicine for those who have accessed treatment? Ikudayisi said the United States of America (USA) Atlanta-based Emory Healthcare claims that 75 to 80 per cent of patients have had significant pain relief and improved function. The USA Mayo Clinic website says that 40 to 70 per cent of patients find some level of pain relief using some of the regenerative medicine protocols.

The physician said the success rate has been generally high both in the USA and Nigeria at all the centres where he worked. He insisted the results differ from one patient to another, and some other centers do have low success rates. I too have had a couple of patients with delayed onset of effectiveness of treatment or patients needing additional or second treatment sessions before they begin to see positive results. It is important to mention or remind ourselves that there is no guarantee in medicine despite the hype surrounding adult stem cell therapy or regenerative medicine as a whole. It does not work 100 percent of the time. Nonetheless, there is a very high success rate amongst the patients with non-bleeding acute stroke when treatment is done within a couple of days to few weeks, with the goal of preventing permanent residual symptoms post stroke. This was evident in all our non-haemorrhagic acute stroke patients that we treated directly at our facility or through consultation in other hospitals, ranging from a top government official to a low-income grandmother. The general rule of thumb is that the earlier the treatment is given in acute injuries, the higher the success rate, Ikudayisi said.

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How regenerative medicine could be used to contain COVID-19, others - Guardian

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Cell Expansion Market Analysis, COVID-19 Impact,Outlook, Opportunities, Size, Share Forecast and Supply Demand 2021-2027|Trusted Business Insights -…

Cell Expansion Market Analysis, COVID-19 Impact,Outlook, Opportunities, Size, Share Forecast and Supply Demand 2021-2027|Trusted Business Insights  TechnoWeekly

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BRTX-100; the Story of BioRestorative Therapies Inc (OTCMKTS: BRTX) – MicroCap Daily

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BioRestorative Therapies Inc (OTCMKTS: BRTXQ) (BRTX) is soaring up the charts after it was revealed at 12.04 pm Wednesday afternoon the Company was emerging from bankruptcy. BRTXQ came to the attention of many penny stock speculators after the Company partnered on a new bankruptcy reorganization plan with one of its creditors Auctus Capital in which it would emerge from bankruptcy with the commons intact, ready to begin phase 2 trials and get BioRestorative back on a national stock exchange.

BioRestorative Therapies has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs. BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. It is the Companys intend that the product be used for the non-surgical treatment of painful lumbosacral disc disorders.

BioRestorative Therapies Inc (OTCMKTS: BRTX) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: Disc/Spine Program (brtxDISC): Its lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders.

The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. The Company has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

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Metabolic Program (ThermoStem): the Company is developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

BioRestorative owns a valuable intelectual property portfolio including unique international Stem Cell patents as well as 8 patents issued, in the United States and other countries, for the Companys brown fat technology related to BioRestoratives metabolic program (ThermoStem Program).

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BioRestorative Therapies is making a powerful move up the charts after it was it was revealed at 12.04 pm Wednesday afternoon the Company was emerging from bankruptcy. This comes after the Company successfully entered into a reorganization plan with one of its creditors Auctus Capital after its March Bankruptcy filing in which the Company would emerge from bankruptcy with the commons intact, ready to begin their phase 2 trials and get BioRestorative back on a national stock exchange. BioRestorative Therapies has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs. BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. It is the Companys intend that the product be used for the non-surgical treatment of painful lumbosacral disc disorders. We will be updating on BioRestorative when more details emerge so make sure you are subscribed to Microcapdaily so you know whats going on with BioRestorative.

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

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