Monthly Archives: May 2020

New hybrid embryos are the most thorough mixing of humans and mice yet – Science News

Posted: May 14, 2020 at 7:43 pm

Scientists have made embryosthat are a lot mouse and a little bit human.

With a little help, human stem cells can knit themselves into growingmouse embryos, populating thedeveloping liver, heart, retina and blood, researchers report May 13 in Science Advances.

Finicky human cells dont tend to grow well in other animals. But in one of the new mouse embryos, 4 percent of its cells were human the most thorough mixing between human and mouse yet.

That level of integration isquite striking to me, says Juan Carlos Izpisua Belmonte, a stem cell anddevelopmental biologist at the Salk Institute for Biological Studies in LaJolla, Calif. If other scientists can replicate the findings, it potentiallyrepresents a major advance, says Izpisua Belmonte, who was not involved in thestudy.

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Such chimeras could helpreveal how a single cell can give rise to an entire organism. More humanizedanimals could also prove valuable in studying diseases such as malaria that affectpeople more than other animals. And with more advances, chimeras couldultimately turn out to be a source of human organs.

Many scientists have hitroadblocks in growing human stem cells in mice or other animals, including pigs and cows(SN: 1/26/17). We have analyzedthousands of embryos but never saw robust chimeric contribution of human stemcells to mouse embryos beyond day 12, says stem cell and developmentalbiologist Jun Wu of the University of Texas Southwestern Medical Center inDallas, who wasnt involved in the study.

The new methods success comes down to timing, says neuroscientist and stem cell biologist Jian Feng. To grow and thrive in a mouse embryo, human stem cells developmental clocks must be turned back to an earlier phase called the nave stage. You need to basically push the human cells back to that phase, says Feng, of the University at Buffalo in New York.

Feng and his colleagues resetthe stem cells clocks by silencing a protein called mTOR for three hours. Thisbrief treatment shocked the cells back to their nave stage, presumably restoringtheir ability to turn into any cell in the body.

Researchers injected batchesof 10 to 12 of these more youthful human stem cells into mouse embryos containingabout 60 to 80 mouse cells, and allowed the embryos to develop for 17 days.

To outward appearances, these embryos grew normally despite harboring human cells. By tallying DNA that was specific to either mouse or human, the researchers found that human cells accounted for between 0.1 and 4 percent of the total cells in the embryos.

Human cells knittedthemselves into most developing tissues of the mouse, destined to become theliver, heart, bone marrow and blood. Human red blood cells were particularlyabundant in these mouse embryos, the researchers found. A small number of humancells showed up in tissue that will form a brain; one embryo had a swarm of humanphotoreceptors, eye cells that help detect light.

As far as the researcherscould tell, no human cells were among the cells that go on to form sperm andegg. The capacity of chimeras to reproduce is one of the worrisome ethicalquestions surrounding the organisms that scientists are still trying to figureout.

Once inside a mouse embryo, the normally sluggish developmental pace of the human cells sped up to match their hosts. Human stem cells typically are slow to turn into certain types of mature photoreceptors, liver cells or red blood cells, Feng says, but not when the human cells are inside a mouse embryo. You put the same human cells in a mouse embryo, [and] they go fast, Feng says. In 17 days, you get all these mature cells that would otherwise take months to get in a normal human embryo.

Other scientists emphasize that different laboratories need to repeat the results. But if it works a big if here this has big implications, Wu says.

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Augustinus Bader Launches The Hand Treatment in Response to COVID-19 Pandemic Exclusive Details – Allure

Posted: May 14, 2020 at 7:43 pm

As a skin-care brand, Augustinus Bader prides itself on releasing products not out of frivolity or trying to up its bottom line, but out of necessity. As Charles Rosier, cofounder and CEO of Augustinus Bader, puts it: "We want to only add product when we feel we are relevant," he tells Allure via phone from Paris, France, where he is currently self-isolating. "Our latest initiative was a reaction to something that we felt was needed by the consumer by everyone."

The brand's newest offering, The Hand Treatment, is meant to be just that. As it stands, given the current COVID-19 situation, we are all washing our hands (or should be) much more than we might otherwise normally do so. However, as you've also likely experienced dry skin and flaking cuticles, just as is the case with everywhere else on the body, overwashing the skin on our hands can bring on a host of issues all their own. Even if you forgo washing for an alcohol-based hand sanitizer, the effects can be just as profound if not more so.

"We are seeing more and more hand dermatitis," explains New York City-based board-certified dermatologist Dhaval Bhanusali, who is not affiliated with Augustinus Bader. "By overwashing, we strip the good oils from our skin and leave it dry and susceptible to breakdown."

Our skin's moisture barrier is responsible for keeping the good things in (like hydration and natural oils) and the bad things out (like allergens and bacteria). When the lipid barrier on the hands (or anywhere on the body) becomes too dried out, it can literally start to break down and lose functionality. Simply put, in order for our skin to function and remain healthy, its barrier must be intact. However, we're not saying that you should stop washing your hands just that it's equally important to replenish hydration after doing so.

That's where Augustinus Bader's new Hand Treatment comes into play. It's formulated with a blend of ultra-nourishing ingredients, including vitamin E, glycerin, and shea butter, as well as honey and white peony extract both of which also have natural antibacterial properties. However, as with all Bader products, the key ingredient is something called TFC8, which stands for its proprietary Trigger Factor Complex-8.

For those unfamiliar with the brand, TFC8 is not one singular ingredient but rather, a proprietary blend of "natural amino acids, high-grade vitamins, and synthesized molecules naturally found in skin," cosmetic chemist Ginger King (who is not affiliated with the brand) previously told Allure. In a nutshell, TFC8 provides an ideal environment in which our skin's stem cells can naturally regenerate it acts as a sort of guide, helping to set the skin's inherent repair system back on track.

"The TCF8 technology focuses on intrinsic repair processes based in intrinsic repair cells, which we call stem cells," Bader explains. "We wanted to develop a hand cream with our technology, which helps to protect and care for the skin."

The results of using TFC8 topically, according to Augustinus Bader himself, a German stem-cell scientist, and his many devotees (our own editor in chief among them), read like a laundry list of skin-care goals: Increased hydration, a strengthened skin barrier, faded fine lines, and dark spots. The proprietary ingredient is, of course, also formulated into the brand's other offerings: two creams for the face, one for the body, and most recently, a makeup primer collaboration with Victoria Beckham Beauty.

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Immupharma lifted by US university study – Proactive Investors UK

Posted: May 14, 2020 at 7:43 pm

() shot up 24% to 17.75p on the back a recent study conducted at Emory University Atlanta in the US.

The study may provide evidence that Immupharmas Lupuzor lupus treatment could help to reduce or prevent the occurrence of the cytokine storm seen in coronavirus patients.

The drug development firm said the findings of the study suggested that coronavirus patients and systemic lupus erythematosus (SLE) sufferers experiencing flares might share similar inflammatory symptoms, underpinned by similar mechanisms.

PLC (), the housebuilder, saw it share price tumble 16% to 310.4p as it reported a huge drop in profits.

The FTSE250 group said it had lost around 184 sales at the end of March when lockdown restrictions were imposed.

These had affected profits by 29mln and pushed up net debt by 83mln.

() tumbled 7% to 1,016.5p after it reported a sharp fall in sales in the first quarter.

The life assurance firms business took a big hit from the effects of coronavirus in China and Hong Kong.

The company said it was continuing to prepare for various ways of spinning off its US arm, Jackson, including a possible minority initial public offer.

(), the learning centres operator, saw its shares dive 16% to 0.4p after a board member resigned.

Ramasamy Jayapal, a non-executive director, has resigned with immediate effect.

() slumped 28% to 0.215p after it issued equity at 0.2p each.

Precious Metal Capital Group took 25mln new shares as per the share subscription deal announced on 2 April.

The share subscription added 50,000 to the coffers of Tertiary and lifted the number of its shares in issue to just over 792mln.

() saw its shares soar 33% to 0.03p as it announced the appointment of experienced journalist Katharine Lewis as a non-executive director.

The multi-divisional new media and technology business noted that Lewis has more than 20 years' experience in senior roles in the media and technology industries, across the UK, US and Asia.

Few others can combine having been at the hard end of both traditional and new digital media with leaders in the fields. She also understands both technology and the process of taking start-ups and early-stage companies and helping them grow into serious businesses, said John Quinlan, the chief executive officer of Iconic.

PLC () leapt 17% higher to 5.5p in early trade on Thursday after the hygiene products group revealed it has signed two new licensing agreements.

The company has agreed on a technology licence over 24, its long-lasting germ-killing sanitiser spray, with a consortium of investors and experienced market professionals operating under the umbrella of Integrated Resources International LLC, based in Tennessee. The initial licence fee is US$250,000 with the company also receiving royalties on sales.

The second agreement has previously been alluded to in the companys announcements and can now be revealed as being an agreement with SC Johnson Professional Ltd for alcohol-free hand sanitisers.

A contract win at () also sent its shares higher, up 9.5% to 1.15p.

The companys Connaught Access Flooring subsidiary has won a 1.2mln gig to install 30,000 square metres of raised access flooring for a commercial office refurbishment project at Canary Wharf, London.

The project is currently live on-site and methods of working and safety procedures have been tailored to meet the requirements introduced to protect site workers against the impact of the coronavirus.

() has noted the results of a recent study conducted at Emory University Atlanta in the US, which it postulates may provide evidence that its Lupuzor lupus treatment couldhelp to reduce or prevent the occurrence of the cytokine storm seen in coronavirus patients. The drug development firm said the findings of the study suggested that coronavirus patients and systemic lupus erythematosus (SLE) sufferersexperiencing flares might share similar inflammatory symptoms, underpinned by similar mechanisms. As Lupuzor is a modulator ofimmune response and an anti-inflammatory agent that has activity against SLE, ImmuPharma said further exploratory work is ongoing to assess the treatments possible potential and clinical program in [coronavirus] patients.

PLCs (LON:TILS, ) chief executive believes the companys StemPrintER technology has the potential to become an essential prognostic tool in the fight against breast cancer. Kunwar Shailubhais comment followedthe release of a scientific abstract ahead of a poster discussion session at the American Society of Clinical Oncologys (ASCO) virtual conference being held later this month. This poster showed the stem cell biology-based genomic tool had greater refinement [than] and superiority [to] than the current market leader, Oncotype DX, in delivering prognostic information on women with ER+/HER2- form of breast cancer. The results were compiled by the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London.

() told investors that it has successfully agreed to amendments to its 5mln loan, with the lender accepting a deferral of all cash interest payments for 2020. In a statement, the company said the agreement withLombard Odier Asset Management will help it preserve its existing cash resources. A quarterly interest payment was due for the three months ended March 31, 2020, and that will no longer be required, with no cash interest payments now payable before March 31, 2021. Echo Energy said: The amendment is a further important step in the successful restructuring of the company's debts and provides a waiver of default for any non-payment of interest previously due under the loan.

() said it has signed a significantplatform deal with a major global telecoms provider. The mobile commerce specialist said the deal will run for an initial period of three years and is worth at least 1.5mln with the opportunity to earn additional revenues. Under the agreement, the telecoms provider will deliver a range of third party products and services to its customers through the Bango Platform and will use data insights to optimise the targeting of product offers.

PLC () (NASDAQ:VRNA) said it has been given the regulatory green light for two phase III studies of the nebulised formulation of its drug for chronic obstructive pulmonary disease (COPD). It followed what is called an End of Phase II meeting with the US Food & Drug Administration (FDA) at which the company was provided clarity by officials on how it should proceed with the trials. Specifically, the FDA provided its input on the dosing, primary and secondary endpoints, patient population and study design.

(), a global leader in fuel cell technology and engineering, has announced the appointment of Mark Garrett as its chief operating officer, joining the executive management board with effect from August 10, 2020. Ceres said Garrett said joins the company from () where he held various positions including chief operating officer and group strategy officer. Garrett succeeds the company's current chief operating officer James Falla, who will leave Ceres in August 2020 to pursue other opportunities.

Holdings PLC () has said findings from one of its studies areto be featured at a prestigious international cancer research conference this month. The immunodiagnostics group announced that its data from profiling tumour associated antibodies in melanoma patients receiving immune checkpoint inhibitors has been selected as a featured presentation at the upcoming American Society of Clinical Oncology 2020 ASCO for short Virtual Scientific Programme, which will take place from May 29 to May 31. The featured presentation will review data assessing samples from patients receiving either Pembrolizumab, Ipilimumab, Nivolumab monotherapy, or combination therapy of Ipilimumab and Nivolumab, which have been analysed on 's proprietary biomarker discovery engine, SeroTag. The data identified that autoantibodies have a role in predicting clinical outcomes or immune-related adverse events (irAEs).

() has said it will present clinical data from an ongoing phase one trial of its MCY-M11 treatment for ovarian cancer and peritoneal mesothelioma at the American Society of Clinical Oncology's upcoming annual meeting. The cell-based therapy specialist said the data, which encompasses the first three cohorts of a dose-escalation trial to demonstrate the safety of MCY-M11 and the feasibility of one-day manufacturing, will be available as a poster presentation in the Developmental Therapeutics: Immunotherapy session from 8am Eastern Time (1pm BST) on May 29. The presentation will be entitled: "Feasibility and preliminary safety and efficacy of first-in-human intraperitoneal delivery of MCY-M11, anti-human-mesothelin CAR mRNA transfected into peripheral blood mononuclear cells, for ovarian cancer and malignant peritoneal mesothelioma."

() has highlighted its resilient business modeland robust financial position in a trading and operations updateahead of Thursday's annual general meeting (AGM). The Kurdistan-focused oil producer noted that it has received US$98mln of cash proceeds in the first four months of 2020, and, as at the end of April, it had US$404mln of cash on account with net cash stated at US$106mln onApril 30, 2020. The group said it spent some US$45mln of capex in the four-month period, though forward expenditure was cut significant as the coronavirus (COVID-19) pandemic took hold. Genel confirmed it is paying US$27.8mln of dividends, at 10 US cents per share, to shareholders on its register on May 29.

Mineral and Financial Investments Limited () saw its net asset value (NAV) rise 10.4% from a year earlier in the first quarter of 2020. NAV rose to 5.3mln from 4.8mln a year earlier while NAV per share jumped 10.6% to 15.1p at the end of March 2020 from 13.6p at the end of March 2019. What the company calls its tactical portfolio broadly benefited from a 5.5% appreciation of the US dollar versus the sterling. Additionally, gradually increasing its weighting in precious metals from the final quarter of 2018was a net positive for performance, the investment company said.

, the supplier of managed services and technology-based security solutions, racked up its fourth consecutive year of double-digit percentage revenue growth in 2019. Reporting numbers for the year ended December 31, 2019, Westminster said its revenues rose 63% to 10.9mln in 2019, up from 6.7mln in 2018, with a 46% increase in recurring revenues to 5.6mln, up from 3.8mln the year before. It pointed out that the current year so far has been a good one with order intake and revenues ahead of budget. Revenues in the first quarter were up 22% year-on-year at 4.5mln with the company making a healthy profit of several hundred thousand pounds in the quarter both before and after-tax as it begins to benefit from new contracts.

() has agreed to pay a US$250,000 deposit, in cash and shares, for its previously announced acquisition of an additional 2.25% interest in the OML 113 asset in Nigeria. "Keeping to our stated plan, we have completed the second stage of this agreement with EER, taking us another step closer to concluding the transaction and increasing our position in OML 113, which is a high-quality asset, Osamede Okhomina, ADM chief executive said in a statement. "Despite the wider, global macroeconomic issues, we believe the longer-term outlook remains very positive within our market.We are focused on continuing to execute our strategy and are well placed to do so having recently strengthened our financial position," he added.

() saw its shares rise on Thursday as it completed a share placing at a premium, raising around 1.14mln. The risk management software firm said it had raised the proceeds through the issue of around 3.8mln new shares at a price of 30p each, a 27.7% premium to its closing price last Thursday, the last trading day before Monday when it unveiled that it had exceeded its fundraising target. KRM22 also said its executive chairman and chief executive, Keith Todd, chief financial officer Kim Suter and non-executive director Steve Sparke intend to make a further equity investment of around 135,000 in the company through asubscription for 499,998 new shares at the placing price. The company said the proceeds of the fundraising will be used for general working capital purposes.

() chairman Simon Oddie has told investors he is encouraged by the progress being made with the onshore Wressle oil field project in Lincolnshire. It comes after the project operator provided an update on the site work, which has been continuing during the coronavirus (COVID-19) pandemic. Four groundwater monitoring boreholes were completed at the Wressle site, as required under the projects approvals, and a three-month period of monitoring and analysis will now take place.

(), a multi-divisional new media and technology business, has announced the appointment of Katharine Lewis a non-executive director. It noted that Lewis has more than 20 years' experience in senior roles in the media and technology industries, across the UK, US and Asia including with Bloomberg in New York, at several digital media start-ups, including eBay, and with Fremantle, one of the world's largest TV and entertainment companies. In 2016 Lewis left Fremantle to create FutureSmartMedia, a media consulting business which advises some of the industry's leading content distributors, publishers and producers. Commenting on her appointment, John Quinlan, chief executive officer of Iconic Labs, said: "We are delighted that Katharine has agreed to join the board, as not only will her seniority and experience help us further improve our corporate governance, but we will also be able to benefit from her considerable sector experience and contacts. Few others can combine having been at the hard end of both traditional and new digital media with leaders in the fields. She also understands both technology and the process of taking start-ups and early-stage companies and helping them grow into serious businesses."

Seeing Machines Limited (), the advanced computer vision technology company that designs AI-powered operator monitoring systems to improve transport safety, said it has appointed Michael Brown as a non-executive director with immediate effect. Brown is a highly experienced financial markets professional based in London and comes to the Seeing Machines board with a deep knowledge of the AIM market and small to mid-cap technology companies, as well as previous plc non-executive and observer board roles. He is currently a portfolio manager within the Volantis team at Lombard Odier Investment Managers. Kate Hill, Seeing Machines chair commented: "We are delighted to welcome Michael to the board of Seeing Machines and look forward to leveraging his deep knowledge and experience of the financial markets in London and New York, and particularly, the AIM market, skills which will nicely complement those of our existing board members. He has been closely associated with the company over the past few years as Lombard Odier's interest has gradually increased and I know Seeing Machines will benefit from his contribution."

Salt Lake Potash Limited () () has announced the appointment of Matt Bungey as a non-executive director with immediate effect. Bungey is a chemical engineer with over 20 years' experience in Natural Resources and was most recently a managing director and Head of Mining and Metals with Barclays Investment Bank in London. He commenced his career as a Process Engineer with BHP at the Centre for Minerals Technology in the United States where he was responsible for process design and research into bacterial leaching of copper-sulphide ore. He then spent several years in the Marketing Division of BHP Billiton based in The Hague. Bungey has worked as a consultant to SO4 since the beginning of 2019 and has played a key role in the advancement of the Lake Way Project. Tony Swiericzuk, Salt Lakes chief executive officer commented: "Since 2019, Matt has made a significant contribution to the rapid advancement of our Lake Way Project. He brings wide-ranging experience in chemical engineering, mining finance and corporate strategy to the SO4 board and is a valuable appointment."

(), specialists in the exploration and production of iodine and manufacturers of speciality chemical products, has announced that its subsidiaries Iofina Chemical Inc., and Iofina Resources Inc., have received loans totalling US$1.09mln under the US Small Business Administration's Paycheck Protection Program (PPP) which is part of the Coronavirus Aid Relief and Economic Security Act (CARES). PPP loans, or a portion of the loan, may be forgivable if loan proceeds are used for eligible purposes, including employee retention and payroll. At this time, the group said, it expects a significant majority of funds received to be eligible for forgiveness under the program. As previously reported on May 4, 2020, brine to Iofinas IO#8 plant has been reduced and the plant is currently not operating at this time. Whilst not certain, the company said it expects viable brine volumes to return to IO#8 in the third quarter of 2020 as the US economy recovers and oil prices stabilize. The company added that its four other IOsorb iodine plants are unaffected and continue to operate as expected.

Silence Therapeutics PLC (LON:SLN), a leader in the discovery, development and delivery of novel RNA therapeutics for the treatment of serious diseases, has announced that its chief financial officer, Dr Rob Quinn will be participating in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on Wednesday, May 20, 2020, at 10.55am EDT (3.55pm BST). A live webcast of the event can be accessed via the Investors section of the company's website at http://www.silence-therapeutics.com . An archived replay of the webcast will be available for 60 days on the website after the conference.

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BeyondSpring Granted New U.S. Patent for Plinabulin to Treat Severe Chemotherapy-Induced Neutropenia from Taxane in Cancer Patients – Stockhouse

Posted: May 14, 2020 at 7:43 pm

NEW YORK, May 13, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the Company” or BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the United States Patent and Trademark Office (USPTO) has granted the Company a new patent, U.S. 10,596,169, for methods of treating severe chemotherapy-induced neutropenia (CIN) from Taxane in cancer patients by administering its lead asset Plinabulin, with protection through 2033.

This is the first U.S. patent establishing Plinabulin’s beneficial effects in reducing CIN associated with taxane, one of the most commonly used chemotherapies,” said Dr. Lan Huang, BeyondSpring’s Co-founder, Chairman and CEO, and the inventor of this patent. Plinabulin’s CIN reduction benefit gives oncologists the potential to optimize care for their patients and give them a better tool to aid in their fight against cancer. This patent is the first of a series of patents that protect Plinabulin’s novel benefits in reducing CIN.”

Plinabulin is currently in Phase 3 global clinical development for CIN prevention and non-small cell lung cancer (NSCLC) treatment. BeyondSpring currently owns 74 patents related to Plinabulin and its analogs, which have been granted in 36 jurisdictions, including 16 U.S. patents, with protection through 2036.

About BeyondSpring BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring’s lead asset, first-in-class agent Plinabulin as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.

About Plinabulin Plinabulin, BeyondSpring’s lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts Caitlin Kasunich / Raquel Cona KCSA Strategic Communications 212.896.1241 / 212.896.1276 ckasunich@kcsa.com / rcona@kcsa.com

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Global Stem Cell Therapy Market Forecast & Opportunities, 2025 – ResearchAndMarkets.com – Business Wire

Posted: May 14, 2020 at 7:42 pm

DUBLIN--(BUSINESS WIRE)--The "Global Stem Cell Therapy Market By Type (Allogeneic, Autologous, Syngeneic), By Source of Stem Cells (Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood derived, iPSCs, Others), By Application, By End Users, By Region, Forecast & Opportunities, 2025" report has been added to ResearchAndMarkets.com's offering.

The Global Stem Cell Therapy Market is expected to grow at a formidable rate of around 12% during the forecast period. The industry is segmented based on type, source of stem cells, application, end-users, company and region.

The market is driven by the growing popularity and awareness pertaining to the use of stem cells for the prevention and cure of certain life threatening diseases. Additionally, increase in number of stem cell banks and growing investments by the government and private organizations for the development of stem cell preservation infrastructure is further propelling the market across the globe.

Based on type, the market can be categorized into allogeneic, autologous and syngeneic. The allogenic type segment is expected to register the highest growth during forecast period attributable to the rising commercialization of allogeneic stem cell therapy products, wider therapeutic applications of allogeneic stem cells, easy production scale-up process, growing number of clinical trials related to allogeneic stem cell therapies, among others.

Based on end-users, the market can be bifurcated into hospitals and clinics. The hospitals segment is expected to dominate the market during the forecast years. This can be accredited to the rising preference for stem cell therapies offered by hospitals proves beneficial for the business growth. Hospitals have affiliations with research laboratories and academic institutes that carry out research activities for developing stem cell therapies. On introduction and approval of any novel stem therapy, hospitals implement it immediately.

Regionally, the stem cell therapy market has been segmented into various regions namely Asia-Pacific, North America, South America, Europe, and Middle East & Africa. Among these regions, North America is expected to dominate the overall stem cell therapy market during the next five years on account of the increasing number of clinical trials for stem cell-based products and increasing public-private funding & research grants.

Major players operating in the Global Stem Cell Therapy Market include Osiris Therapeutics, Inc., MEDIPOST Co., Ltd., Anterogen Co., Ltd., Pharmicell Co., Ltd., Holostem Terapie Avanzate S.r.l., JCR Pharmaceuticals Co., Ltd., NuVasive, Inc., RTI Surgical, Inc., AlloSource, Thermo Fisher Scientific and others. The companies are developing advanced technologies and launching new services in order to stay competitive in the market.

Years considered for this report:

Objective of the Study

Key Topics Covered

1. Product Overview

2. Research Methodology

3. Executive Summary

4. Voice of Customer

5. Global Stem Cell Therapy Market Outlook

5.1. Market Size & Forecast

5.1.1. By Value

5.2. Market Share & Forecast

5.2.1. By Type (Allogeneic, Autologous, Syngeneic)

5.2.2. By Source of Stem Cells (Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood Derived, iPSCs, Others)

5.2.3. By Application (Musculoskeletal, Wound & Injury, Cardiovascular Disease (CVD), Surgery, Acute Graft-Versus-Host Disease, Drug Discovery & Development, Others)

5.2.4. By End Users (Hospitals v/s Clinics)

5.2.5. By Company (2019)

5.2.6. By Region

5.3. Product Market Map

6. Asia-Pacific Stem Cell Therapy Market Outlook

7. Europe Stem Cell Therapy Market Outlook

8. North America Stem Cell Therapy Market Outlook

9. South America Stem Cell Therapy Market Outlook

10. Middle East and Africa Stem Cell Therapy Market Outlook

11. Market Dynamics

11.1. Drivers

11.2. Challenges

12. Market Trends & Developments

13. Competitive Landscape

13.1. Osiris Therapeutics, Inc.

13.2. MEDIPOST Co. Ltd.

13.3. Anterogen Co. Ltd.

13.4. Pharmicell Co. Ltd.

13.5. Holostem Terapie Avanzate S.r.l.

13.6. JCR Pharmaceuticals Co. Ltd.

13.7. NuVasive, Inc.

13.8. RTI Surgical, Inc.

13.9. AlloSource

13.10. Thermo Fisher Scientific

14. Strategic Recommendations

For more information about this report visit https://www.researchandmarkets.com/r/hmawq6

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Stem Cell Therapy | Global Industry Review 2015-2019 and Forecast to 2025 – PRNewswire

Posted: May 14, 2020 at 7:42 pm

DUBLIN, May 13, 2020 /PRNewswire/ -- The "Global Stem Cell Therapy Market By Type (Allogeneic, Autologous, Syngeneic), By Source of Stem Cells (Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood derived, iPSCs, Others), By Application, By End Users, By Region, Forecast & Opportunities, 2025" report has been added to ResearchAndMarkets.com's offering.

Years considered for this report:

Objective of the Study

Key Topics Covered

1. Product Overview

2. Research Methodology

3. Executive Summary

4. Voice of Customer

5. Global Stem Cell Therapy Market Outlook5.1. Market Size & Forecast5.1.1. By Value5.2. Market Share & Forecast5.2.1. By Type (Allogeneic, Autologous, Syngeneic)5.2.2. By Source of Stem Cells (Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood Derived, iPSCs, Others)5.2.3. By Application (Musculoskeletal, Wound & Injury, Cardiovascular Disease (CVD), Surgery, Acute Graft-Versus-Host Disease, Drug Discovery & Development, Others)5.2.4. By End Users (Hospitals v/s Clinics)5.2.5. By Company (2019)5.2.6. By Region5.3. Product Market Map

6. Asia-Pacific Stem Cell Therapy Market Outlook

7. Europe Stem Cell Therapy Market Outlook

8. North America Stem Cell Therapy Market Outlook

9. South America Stem Cell Therapy Market Outlook

10. Middle East and Africa Stem Cell Therapy Market Outlook11. Market Dynamics11.1. Drivers11.2. Challenges

12. Market Trends & Developments

13. Competitive Landscape13.1. Osiris Therapeutics, Inc.13.2. MEDIPOST Co. Ltd.13.3. Anterogen Co. Ltd.13.4. Pharmicell Co. Ltd.13.5. Holostem Terapie Avanzate S.r.l.13.6. JCR Pharmaceuticals Co. Ltd.13.7. NuVasive, Inc.13.8. RTI Surgical, Inc.13.9. AlloSource13.10. Thermo Fisher Scientific

14. Strategic Recommendations

For more information about this report visit https://www.researchandmarkets.com/r/j7namd

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

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Cardio Stem Cell Therapy Used to Treat Critically Ill Covid-19 Patients – Physician’s Weekly

Posted: May 14, 2020 at 7:42 pm

Four of six patients in case series were weaned off respiratory support

An investigational allogeneic cell therapy using cardiosphere-derived cells (CDC) showed an acceptable safety profile with early evidence of efficacy in the treatment of very severe Covid-19 in a case series involving six patients treated at Cedars-Sinai Medical Center in Los Angeles.

All six patients treated with the intravenous allogeneic CDC formulation CAP-1002 (Capricor Therapeutics) as a compassionate therapy required respiratory support prior to treatment, with five on mechanical ventilation.

No adverse events related to the treatment were reported, and four of the six patients were successfully weaned from respiratory support and were discharged from the hospital as of late April.

The other two patients are still alive, but remain intubated, Cedars-Sinai cardiologist Raj Makkar, MD, confirmed to BreakingMED Wednesday, May 13.

While we are encouraged by these findings, it is important to point out that the only way that we can assess the efficacy of this treatment in a definitive way is with a randomized clinical trial, and that is what we intend to do, Makkar said.

He added that the clinical trial, which is in the planning stages, is likely to include Covid-19 patients who are not as critically ill as the six in the case series.

All of these patients required respiratory support and they were all on a downward trajectory when treated, he said. They were getting worse and we had nothing else to offer them.

Cardiosphere-derived cells are stromal/progenitor cells from heart tissue with a distinctive antigenic profile (CD105+, CD45-, CD90low).

In their case series, published in the journal Basic Research in Cardiology, Makkar and colleagues noted that the cells are entirely distinct from the controversial c-kit+ putative cardiac progenitors, which have been the subject of various retracted studies.

Since CDCs were first isolated in 2007, the cells have been tested in more than 200 patients in clinical trials for a variety of conditions with a good safety profile, including in young boys with Duchenne muscular dystrophy.

Makkar said the anti-inflammatory and antifibrotic properties of CDCs in animal models make them a possible target therapy for Covid-19.

The prior testing gave us reasonable confidence that this treatment was safe, he said, adding that there is also evidence of a favorable effect on the same type of proinflammatory cytokines that are up-regulated in Covid-19.

Comparisons to mesenchymal stem cells (MSCs) in pre-clinical models suggest that CDCs may also be more effective for paracrine factor secretion and myocardial remodeling.

Given the safety record of CDCs in humans, and the substantial body of evidence confirming relevant disease-modifying bioactivity, applicability to Covid-19 seemed compelling, particularly in the hyperinflammatory stage of the illness, the researchers wrote.

All six patients treated with the intravenous CDC formulation had severe, confirmed Covid-19 with respiratory failure and they were not receiving any other experimental agent, with the exception of hydroxychloroquine and tocilizumab.

Lack of clinical improvement or deterioration despite standard care was the primary reason for considering patients for treatment with CAP-1002. Exclusion criteria included known hypersensitivity to DMSO, which is a component of CAP-1002; prior stem cell therapy; pre-existing terminal illness; and need for mechanical circulatory support and dialysis.

In general, patients with multi-organ failure who were deemed to be too sick for any intervention were excluded from the study, Makkar and colleagues wrote.

All patients had acute respiratory distress syndrome (ARDS) prior to infusion, with decreased PaO2/FiO2 ratios (range 69-198; median 142), diffuse bilateral pulmonary infiltrates on chest imaging and evidence of preserved cardiac function on transthoracic echocardiography (LVEF range, 50-75%). SOFA scores ranged from 2 to 8 prior to stem cell treatment.

The six patients (age range, 19-75 years) had IV infusions of CAP-1002 containing 150 million allogeneic CDCs, and two of the six had a second dose of the treatment.

Following treatment, four patients (67%) were weaned from respiratory support and discharged from the hospital.

A contemporaneous control group of critically ill Covid-19 patients (n = 34) at our institution showed 18% overall mortality at a similar stage of hospitalization, the researchers wrote.

Ferritin was elevated in all patients at baseline (range of all patients 605.43-2991.52 ng/ml) and decreased in five of the six patients (range of all patients 252.891029.90 ng/ml).

Absolute lymphocyte counts were low in five of the six patients at baseline (range 0.260.82 103/l) but had increased in 3 of these five at last follow-up (range 0.231.02 103/l).

Administration of CAP-1002 as a compassionate therapy for patients with severe Covid-19 and significant comorbidities was safe, well tolerated without serious adverse events, and associated with clinical improvement, as evidenced by extubation (or prevention of intubation, the researchers wrote.

Stem cell therapy utilizing cardiosphere-derived cells (CDC) showed an acceptable safety profile with early evidence of efficacy in the treatment of very severe Covid-19 in an early case series involving 6 patients treated at Cedars-Sinai Medical Center, Los Angeles.

No adverse events related to the treatment were reported, and four of the six patients were successfully weaned from respiratory support and were discharged from the hospital.

Salynn Boyles, Contributing Writer, BreakingMED

Funding for this story was provided by the Smidt Family Foundation. The cell product, CAP-1002, was provided by manufacturer Capricor Therapeutics.

ResearcherEduardo Marban reported owning founders equity in Cariricor Therapeutics, and researcher Linda Marban reported being an employee and owning equity in the company.

Cat ID: 125

Topic ID: 79,125,254,930,287,728,932,570,574,730,933,125,190,926,192,927,151,928,925,934

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One year on, Capricor’s stem cell therapy appears to help DMD patients in small study, but investors balk at the data – Endpoints News

Posted: May 14, 2020 at 7:42 pm

Repeated setbacks aside, little Capricor has suggested it has generated some long-term data to support its pursuit to garner approval for its stem cell therapy for Duchenne muscular dystrophy, although some of the data appeared to underwhelmed investors.

The data from the small, placebo-controlled mid-stage study, HOPE-2, tracked the effects of the companys stem cell therapy CAP-1002, which is designed to temper the inflammation associated with DMD, in 8 boys and young men who are in advanced stages of DMD. The remaining 12 enrolled patients received the placebo.

The main goal of the study was a measure that evaluates shoulder, arm and hand strength in patients who are generally non-ambulant (performance of the upper limb (PUL) 2.0), as suggested by the FDA, Capricor said. It is one of several ways Capricor quantified skeletal muscle improvement in the trial.

The intravenous infusion of CAP-1002, given every 3 months, induced a statistically meaningful improvement of 2.4 points (p=0.05) versus the placebo group, in which patient declines were consistent with natural history data. However, on another measure of upper limb function, the trend was in favor of the Capricor drug, but did not hit statistical significance.

The companys shares $CAPR were down nearly 13% to $6.89 in morning trading.

Click on the image to see the full-sized version

Meanwhile, there were also some encouraging data on cardiac function the genetic condition is characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.

As reflected above, CAP-1002 elicited an improvement across different measures of cardiac function, although the effect was not always statistically significant. In particular, the drug also caused a reduction in the levels of the biomarker CK-MB, an enzyme that is only released when there is cardiac muscle cell damage.

Armed with these data and an RMAT and orphan drug designation from the FDA, Capricor is now hoping to eke out a plan with the FDA for marketing approval.

LA-based Capricor initially set out to test the potential of technology that Eduardo Marbn, CEO Linda Marbns husband, developed at Johns Hopkins. But repeated setbacks clobbered the company, which in 2014 traded north of $14 a share. In 2017, J&J walked away from a collaboration on a stem cell therapy for damaged hearts after it flopped in the clinic.

In late 2018, the company voluntarily halted a DMD clinical trial, following a severe allergic reaction that occurred during infusion. In February 2019, the company said it is exploring strategic alternatives for one or more of its products and cutting 21 jobs to keep financially afloat, but had resumed dosing in its DMD trial.

The first batch of positive data on CAP-1002, which consists of progenitor cells derived from donor hearts and is designed to exude exosomes that initiate muscle repair by suppressing inflammation and driving immunomodulation, came last July when the company announced the drug had generated a positive effect at the interim analysis juncture of HOPE-2. Capricor is now working on to flexing its therapeutic muscle with CAP-1002 to fight the Covid-19 pandemic.

DMD is a rare muscle-wasting disease caused by the absence of dystrophin, a protein that helps keep muscle cells intact. It disproportionately affects boys and affects roughly 6,000 in the United States.

Patients are essentially treated with steroids. Sarepta Therapeutics now has two exon-skipping drugs designed to treat certain subsets of the disease, although the magnitude of their effect is controversial given that approvals were not based on placebo-controlled data. Meanwhile, Sarepta and others are also pursuing one-time cures in the form of gene therapies to replace the missing dystrophin gene in patients.

Social: Linda Marbn, Capricor CEO (Twitter)

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Australia’s Mesoblast raises $90M to scale up stem cell therapy manufacturing to treat COVID-19 ARDS – BioWorld Online

Posted: May 14, 2020 at 7:42 pm

PERTH, Australia Australian stem cell company Mesoblast Ltd. completed a capital raising of AU$138 million (US$90 million) to scale up manufacturing of its allogeneic cell therapy, remestemcel-L, to treat COVID-19 acute respiratory distress syndrome (ARDS).

The Melbourne-headquartered company is currently enrolling patients in a randomized placebo-controlled phase II/III trial in up to 300 patients across 30 sites in the U.S. The trial is evaluating whether remestemcel-L can reduce the high mortality in COVID-19 patients with moderate to severe ARDS.

Patients are being dosed, and were really pleased how fast enrollment is growing, Mesoblast CEO Silviu Itescu told BioWorld. Were right on target and hope to update the market soon.

The phase II/III trial was initiated after promising results were seen with remestemcel-L under an emergency compassionate-use protocol in COVID-19 ARDS at Mount Sinai Hospital in New York, where nine of 12 (75%) ventilator-dependent patients were able to come off ventilators within 10 days.

Under the compassionate-use protocol, patients in intensive care units received standard-of-care treatment. Once they were intubated on a ventilator, they were treated within 72 hours with two infusions of Mesoblasts remestemcel-L cells within five days.

Once youre ventilated when you have acute respiratory distress syndrome in the lungs, your likelihood of coming off a ventilator is 9%, and your survival is 12%, Itescu said.

Whats exciting is that our patients in the same epicenter of this disease with the same treatment everyone else is getting, suddenly 75% are coming off of ventilators within 10 days, and weve got 83% survival, Itescu said.

The compassionate-use treatment experience informed the design of the phase II/III trial, and the FDA approved the same protocol, but it is powered so that results will be self-evident, Itescu said.

The phase II/III trial will randomize up to 300 ventilator-dependent patients in intensive care units to either remestemcel-L or placebo on top of standard of care, in line with guidance provided by the FDA. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support.

What people are dying of is acute respiratory distress syndrome, which is the bodys immune response to the virus in the lungs, and the immune system goes haywire, and in its battle with the virus it overreacts and causes severe damage to the lungs, he said.

Capital raise allows scale up for COVID-19 and influenza

The capital raise consisted of a placement of 43 million shares to existing and new institutional investors at a price of AU$3.20 per share, representing a 7% discount to the five-day volume-weighted average price (VWAP) at the close of trading May 8. The placement was conducted with Bell Potter Securities as lead manager and underwriter. Settlement is expected to occur on Friday, May 15.

Most of the funds raised will be used to scale up manufacturing of remestemcel-L for the treatment of critically ill patients suffering with diseases causing ARDS, including COVID-19 and influenza.

Were in the middle of a pandemic, and people are talking about opening up, and theyre talking about a potential second wave, Itescu said. Its too early to talk about projections, but we need to at least be in a position to make more product in an additional facility, so that requires technology transfer and certain process improvements.

Remestemcel-L is Mesoblasts lead product, and it is currently being studied in multiple indications so the move to ramp up manufacturing is a good strategic move regardless of COVID-19, he said.

There are at least 125,000 patients every year in the United States with influenza-related acute respiratory distress syndrome in intensive care units, and those patients have got about a 40% fatality rate. Up to about 60,000 patients die per year due to influenza ARDS, so even if COVID-19 magically disappears, which we could only hope, influenza is here to stay despite vaccines being available, the CEO said.

This product would work in the same way for influenza-related ARDS as it would for COVID-19-related ARDS, he said.

The ability to build out manufacturing capacity is part of an FDA requirement to be able to demonstrate it can make product for patients in the U.S.

The company already has a manufacturing facility in Singapore, and the additional site in the U.S. would give the company the ability to provide product globally.

Were putting our strategic plan into play. You need to have multiple geographies, especially in this kind of environment, Itescu said.

Without the cash, we wouldnt have been able to deliver on this, but we now can execute.

Mesoblast's allogeneic candidates are based on mesenchymal lineage cells collected from the bone marrow of healthy adult donors.

Remestemcel-L is currently being reviewed by the FDA for potential approval in the treatment of children with steroid-refractory acute graft-vs.-host disease (aGVHD). The company submitted the final module of a rolling BLA in January. The FDA has set a PDUFA date of Sept. 30 for the product branded as Ryoncil.

The clinical data submitted with the BLA showed a survival rate of 79% compared to an expected 30% survival rate in the pediatric phase III trial in aGVHD.

Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing phase III trials in advanced heart failure and chronic low back pain.

Mesoblast shares (ASX:MSB) were down 1.45% on the news, trading at AU$3.39 per share by market close May 13. On Nasdaq (MESO), shares closed at $12.15.

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AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update – Business Wire

Posted: May 14, 2020 at 7:42 pm

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

The human tragedy of this pandemic has long tentacles that effect numerous businesses including AgeX, said Greg Bailey M.D., Chairman. Given the current global economic landscape, and the changes that businesses will need to make to accommodate to a post pandemic world, we feel that new business model aligns well to be able to function in this new environment. We see enormous opportunity to license and joint venture PureStem and HLA-G while implementing a definitive plan to begin preclinical trials on tissue regeneration under the leadership of Michael West and Michael May. We will update you in the future as these plans progress.

AgeX has completed a company restructuring to help set it up for success in the future. The combination of company priorities, cash position and the COVID-19 pandemic led to employee lay-offs designed to support the evolution of AgeX's current team to execute on strategic business goals going forward and to ensure cash is directed at near-term priorities to deliver maximum shareholder value. AgeX has a dual business strategy to diversify risk and maximize opportunities. It plans to continue to pursue its licensing and collaboration strategy for its two primary technology platforms, UniverCyte immunotolerance technology for the generation of universal cells, and PureStem cell derivation and manufacturing technology for the production of therapeutic cells with potential advantages, including industrial scalability and lower manufacturing costs. Since the launch of its licensing and collaboration strategy in January 2020, AgeX has delivered a research collaboration in Japan focused on developing universally transplantable cells for therapeutic use based on UniverCyte, entered into a neural stem cell therapy research collaboration for neurological disorders utilizing PureStem at a California University, and AgeX licensee ImStem Biotechnology received the first-ever clearance of a cell therapy derived from AgeXs embryonic stem cells by the FDA to enter human studies.

In addition, AgeX remains committed to pursuing in-house cell therapy product development and plans to raise money to build the optimal team to deliver on its products, AGEX-BAT1 for metabolic diseases such as type II diabetes and AGEX-VASC1 for tissue ischaemia. AgeXs budgetary and personnel adjustments will result in the deferral of in-house product development and may also lead to AgeX seeking arrangements with other companies in the cell therapy or biopharma industry for the development of its product candidates and technology, or outsourcing of some of that work to service providers until further funding can be obtained to rebuild in-house research and development staff for one or more of those programs. Development of AgeXs iTR technology may be done at AgeXs subsidiary Reverse Bioengineering, Inc. subject to successful financing of the subsidiary.

Upwards of 80% of healthcare expenditures in the United States relates to chronic degenerative disease and aging is a principle underlying cause of such conditions, said Michael D. West, Ph.D., AgeXs Chief Executive Officer. Therefore, the ability to manufacture to scale young clinical-grade cells capable of regenerating functionality in diverse tissues of the body has the potential to transform healthcare as we know it today. Perhaps even more noteworthy is the potential of reversing developmental aging in the body itself through AgeXs iTR technology. Our goal in the coming year is to advance the development of our intellectual property with the goal of bringing value to our shareholders.

Q1 Highlights

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. On April 1, 2020 AgeX drew the initial $500,000, 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 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 Report on Form 10-Q filed with the Securities and Exchange Commission on March 30, 2020 and May 14, 2020, respectively.

On April 13, 2020, AgeX obtained a loan in the amount of $432,952 from Axos Bank under the Paycheck Protection Program (the PPP Loan). The PPP Loan will bear interest at a rate of 1% per annum. No payments will be due on the PPP Loan during a six month deferral period commencing on the date of the promissory note. Commencing one month after the expiration of the deferral period, and continuing on the same day of each month thereafter until the maturity date of the PPP Loan, monthly payments of principal and interest will be due, in an amount required to fully amortize the principal amount outstanding on the PPP Loan by the maturity date. The maturity date is April 13, 2022. The principal amount of the PPP Loan is subject to forgiveness under the PPP to the extent that PPP Loan proceeds are used to pay expense permitted by the PPP, including payroll, rent, and utilities (collectively, Qualifying Expenses), during the time frame permitted by the PPP. AgeX intends to use the PPP Loan amount for Qualifying Expenses. However, no assurance is provided that AgeX will obtain forgiveness of the PPP Loan in whole or in part.

Staff Reductions

During April 2020, AgeX initiated staff layoffs that affected 12 employees, primarily research and development personnel. AgeX has paid approximately $105,000 in accrued payroll and unused paid time off and other benefits and expects to recognize approximately $194,800 in restructuring charges in connection with the reduction in staffing, consisting of contractual severance and other employee termination benefits, substantially all of which are expected to be settled in cash. The staff reductions followed AgeXs strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic.

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 in excess of an initial $500,000 advance under the New Loan Agreement will be subject to Juvenescences discretion, AgeX believes that its cash and cash equivalents, the $500,000 loan under the New Loan Agreement, the PPP Loan 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 months ended March 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

First Quarter 2020 Operating Results

Revenues: Total Revenues for the first quarter of 2020 were $515,000 as compared with $388,000 for the first quarter of 2019. AgeX revenue is primarily generated from subscription and advertising revenues from the GeneCards online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $86,000 of allowable expenses under its research grant from the NIH as compared with $15,000 in the same period in 2019.

Operating expenses: Operating expenses reported for the three months ended March 31, 2020 were $3.7 million as compared to $3.4 million for the same period in 2019. On an as-adjusted basis, operating expenses for the three months ended March 31, 2020 were $3.2 million as compared to $2.8 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 increased by $0.3 million to $1.6 million during the three months ended March 31, 2020 from $1.3 million during the same period in 2019. The increase was primarily attributable to an increase of $0.2 million in scientific consultants, $0.2 million in laboratory facilities and equipment related expenses and maintenance, $0.1 million in personnel related expenses allocable to research and development, and $0.1 million in depreciation and amortization of laboratory equipment and improvements. These increases were offset to some extent by a decrease of $0.3 million in shared services from Lineage Cell Therapeutics, Inc. (Lineage) with the termination of the Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses for the three months ended March 31, 2020 remained consistent with the same period in 2019 of $2.1 million despite bearing the full lease and facilities related costs since April 2019, and an increase in head count with the employment of AgeXs own finance team since October 1, 2019. These increases were offset by a decrease in 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 for human aging. Its 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. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. 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 Report 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)

March 31,

2020

December 31,

2019

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

468

2,352

Accounts and grants receivable, net

366

363

Prepaid expenses and other current assets

1,238

1,339

Total current assets

2,072

4,054

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Monthly Archives: May 2020

New hybrid embryos are the most thorough mixing of humans and mice yet – Science News

Augustinus Bader Launches The Hand Treatment in Response to COVID-19 Pandemic Exclusive Details – Allure

Immupharma lifted by US university study – Proactive Investors UK

BeyondSpring Granted New U.S. Patent for Plinabulin to Treat Severe Chemotherapy-Induced Neutropenia from Taxane in Cancer Patients – Stockhouse

Global Stem Cell Therapy Market Forecast & Opportunities, 2025 – ResearchAndMarkets.com – Business Wire

Stem Cell Therapy | Global Industry Review 2015-2019 and Forecast to 2025 – PRNewswire

Cardio Stem Cell Therapy Used to Treat Critically Ill Covid-19 Patients – Physician’s Weekly

One year on, Capricor’s stem cell therapy appears to help DMD patients in small study, but investors balk at the data – Endpoints News

Australia’s Mesoblast raises $90M to scale up stem cell therapy manufacturing to treat COVID-19 ARDS – BioWorld Online

AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update – Business Wire

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