Monthly Archives: May 2020

CFIUS and Critical Technologies: Implications for the Biotechnology and Life Sciences Sector – JD Supra

Posted: May 9, 2020 at 9:53 am

Updated: May 25, 2018:

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CFIUS and Critical Technologies: Implications for the Biotechnology and Life Sciences Sector - JD Supra

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Airbus and Koniku Inc. team on biotechnology solutions for aviation security operations – Intelligent Aerospace

Posted: May 9, 2020 at 9:53 am

TOULOUSE, France - Airbus and Koniku Inc. have made a significant step forward in the co-development of a solution for aircraft and airport security operations, by extending research activities to include biological hazard detection capabilities, as well as chemical and explosive threats.

The disruptive biotechnology solution, which was originally focused on the contactless and automated detection, tracking and location of chemicals and explosives on-board aircraft and in airports, is now being adapted, in light of the COVID-19 crisis, to include the identification of biological hazards.

Based on the power of odor detection and quantification found in nature, the technical solution, developed to meet the rigorous operational regulatory requirements of aircraft and airport security operations, uses genetically engineered odorant receptors that produce an alarm signal when they come into contact with the molecular compounds of the hazard or threat that they have been programmed to detect.

Airbus and Koniku Inc. entered into a cooperation agreement in 2017, leveraging Airbus expertise in sensor integration and knowledge of ground and on-board security operations within the aviation and defense industries as well as Konikus biotechnology know-how for automated and scalable volatile organic compound detection (via their Konikore platform).

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Airbus and Koniku Inc. team on biotechnology solutions for aviation security operations - Intelligent Aerospace

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Avid Bioservices and Aragen Bioscience Enter Agreement to Offer Biotechnology and Pharmaceutical Clients Integrated Solution for Cell Line and Process…

Posted: May 9, 2020 at 9:53 am

TUSTIN, Calif. and MORGAN HILL, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, and Aragen Bioscience, a leading contract research organization (CRO) focused on accelerating pre-clinical biologics product development, today announced a co-marketing agreement that will provide clients an integrated sequence-to-manufacturing service. Under terms of the non-exclusive agreement, the companies will offer customers Aragens cell line development expertise integrated with Avids upstream and downstream process development and analytical services to drive efficiencies and reduce overall timelines for delivering CGMP bulk drug substances.

With pharmaceutical and biotechnology companies focused on delivering their innovative medicines to patients as quickly as possible, this alliance aims to speed the entire CGMP manufacturing process by having a single, integrated team oversee a single, integrated project timeline with significant built-in process efficiencies, saidTimothy Compton, chief commercial officer of Avid. We view this collaboration with Aragen as a significant win for current and future clients of both companies and we are excited to contribute our deep CDMO expertise to the partnership, particularly our more than 15 years of commercial product manufacturing experience.

I am excited about this partnership that will enable us to accelerate drug development timelines and deliver new biologic therapeutics to patients faster by integrating two best-in-class offerings to our customers, said Axel Schleyer, CEO of Aragen. Our services in discovery, cell line development, which includes our innovative RapTr platform, protein production and preclinical testing are a great match with Avids clinical and commercial manufacturing capabilities. We look forward to this collaboration that advances novel ideas into breakthrough medicines.

AboutAvid Bioservices, Inc.

Avid Bioservicesis a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization.www.avidbio.com

About Aragen Bioscience, Inc.

Aragen Bioscience, Inc., a wholly owned subsidiary of GVK BIO, is a leading contract research organization based in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of in vitro and in vivo services for the discovery, production, characterization, activity and efficacy assessment and development of biologic and diagnostic products. http://www.aragenbio.com

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Avid Bioservices and Aragen Bioscience Enter Agreement to Offer Biotechnology and Pharmaceutical Clients Integrated Solution for Cell Line and Process...

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COVID-19 pandemic Agricultural Biotechnology Market 2019 | Growing Rapidly with Significant CAGR, Leading Players, Innovative Trends and Expected…

Posted: May 9, 2020 at 9:53 am

Research report on Agricultural Biotechnology Market size | Industry Segment by Applications, by Type, Regional Outlook, Market Demand, Latest Trends, Agricultural Biotechnology Industry Share & Revenue by Manufacturers, Company Profiles, Growth Forecasts 2025. Analyzes current market size and upcoming 5 years growth of this industry.

Report Covers Global Industry Analysis, Size, Share, CAGR, Trends, Forecast And Business Opportunity.

Download Premium Sample Copy Of This Report: https://brandessenceresearch.biz/Request/Sample?ResearchPostId=166135&RequestType=Sample

Global Agricultural Biotechnology Market valued approximately USD XXX billion in 2016 is forecasted to grow with a healthy growth rate of more than XX% over the forecast period 2018-2025. The major factors speculated to augment the markets are growing population size, globally increasing transgenic crops demand due to increasing food requirements, rising per capita income. Agricultural biotechnology, also known as agritech, is an area of agricultural science that uses scientific tools and techniques, including genetic engineering, molecular markers, molecular diagnostics, vaccines, and tissue culture, to modify living organisms: plants, animals, and microorganisms.

The regional analysis of Global Agricultural Biotechnology Market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. North America region is the leading region across the world in terms of market share. Whereas, owing to countries viz. India, Indonesia, China, and Japan, the Asia Pacific region is expected to exhibit higher growth rate / CAGR over the forecast period 2018-2025.

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Technology:Synthetic BiologyDeoxyribonucleic Acid (DNA) SequencingGenome Editing ToolsRibonucleic Acid (RNA) InterferenceBiochips

By Product:Crop Protection ProductsBiostimulantsBiopesticidesTransgenic SeedsCottonSoybeanFruits & vegetablesMaizeOthers

By Regions:North AmericaU.S.CanadaEuropeUKGermanyAsia PacificChinaIndiaJapanLatin AmericaBrazilMexicoRest of the World

Furthermore, years considered for the study are as follows:Historical year 2015, 2016Base year 2017Forecast period 2018 to 2025

The industry is seeming to be fairly competitive. Some of the leading market players include Bayer AG, Dowdupont Inc., Syngenta AG, BASF SE, Adama Agricultural Solutions Ltd., Certis USA LLC, Evogene Ltd., KWS SAAT SE, Monsanto Company, Vilmorin & CIE, and so on. The fierce competitiveness has made these players spend in product developments to improve the customers requirements.

Target Audience of the Agricultural Biotechnology Market Study:Key Consulting Companies & AdvisorsLarge, medium-sized, and small enterprisesVenture capitalistsValue-Added Resellers (VARs)Third-party knowledge providersInvestment bankersInvestors

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Table of Content:

Market Overview:The report begins with this section where product overview and highlights of product and application segments of the Global Agricultural Biotechnology Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.

Competition by Company:Here, the competition in the Worldwide Global Agricultural Biotechnology Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.

Company Profiles and Sales Data:As the name suggests, this section gives the sales data of key players of the Global Agricultural Biotechnology Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the Global Agricultural Biotechnology Market.

Market Status and Outlook by Region:In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the Global Agricultural Biotechnology Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.

Application or End User:This section of the research study shows how different end-user/application segments contribute to the Global Agricultural Biotechnology Market.

Market Forecast:Here, the report offers a complete forecast of the Global Agricultural Biotechnology Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.

Research Findings and Conclusion:This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.

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We publish market research reports & business insights produced by highly qualified and experienced industry analysts. Our research reports are available in a wide range of industry verticals including aviation, food & beverage, healthcare, ICT, Construction, Chemicals and lot more. Brand Essence Market Research report will be best fit for senior executives, business development managers, marketing managers, consultants, CEOs, CIOs, COOs, and Directors, governments, agencies, organizations and Ph.D. Students.

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COVID-19 pandemic Agricultural Biotechnology Market 2019 | Growing Rapidly with Significant CAGR, Leading Players, Innovative Trends and Expected...

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Nanoparticles in Biotechnology and Pharmaceuticals Market Future Growth by In Depth Industry Analysis, Size, Trends and Forecast to 2026 – Cole of…

Posted: May 9, 2020 at 9:53 am

Shire

The scope of the Report:

The report analyzes the key opportunities, CAGR, and Y-o-Y growth rates to allow readers to understand all the qualitative and quantitative aspects of the Nanoparticles in Biotechnology and Pharmaceuticals market. A competition analysis is imperative in the Nanoparticles in Biotechnology and Pharmaceuticals market and the competition landscape serves this objective. A wide company overview, financials, recent developments, and long and short-term strategies adopted are par for the course. Various parameters have been taken into account while estimating market size. The revenue generated by the leading industry participants in the sales of Nanoparticles in Biotechnology and Pharmaceuticals across the world has been calculated through primary and secondary research. The Nanoparticles in Biotechnology and Pharmaceuticals Market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Highlights of the Nanoparticles in Biotechnology and Pharmaceuticals market study:

Speculations for sales:

The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Nanoparticles in Biotechnology and Pharmaceuticals market. Additionally, it includes a share of every segment of the Nanoparticles in Biotechnology and Pharmaceuticals market, giving methodical information about types and applications of the market.

Key point summary of the Nanoparticles in Biotechnology and Pharmaceuticals market report:

This report gives a forward-looking prospect of various factors driving or restraining market growth.

It presents an in-depth analysis of changing competition dynamics and puts you ahead of competitors.

It gives a six-year forecast evaluated on the basis of how the market is predicted to grow.

It assists in making informed business decisions by creating a pin-point analysis of market segments and by having complete insights of the Nanoparticles in Biotechnology and Pharmaceuticals market.

This report helps users in comprehending the key product segments and their future.

Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Nanoparticles in Biotechnology and Pharmaceuticals market

Chapter 2: Evaluating the leading manufacturers of the global Nanoparticles in Biotechnology and Pharmaceuticals market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Nanoparticles in Biotechnology and Pharmaceuticals market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

Finally, the report global Nanoparticles in Biotechnology and Pharmaceuticals market describes Nanoparticles in Biotechnology and Pharmaceuticals industry expansion game plan, the Nanoparticles in Biotechnology and Pharmaceuticals industry knowledge supply, appendix, analysis findings and the conclusion. It includes a through explanation of the cutting-edging technologies and investments being made to upgrade the existing ones.

Report customization:

Verified Market Research also provides customization options to tailor the reports as per client requirements. This report can be personalized to cater to your research needs. Feel free to get in touch with our sales team, who will ensure that you get a report as per your needs.

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Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyse data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise and years of collective experience to produce informative and accurate research.

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Nanoparticles in Biotechnology and Pharmaceuticals Market Future Growth by In Depth Industry Analysis, Size, Trends and Forecast to 2026 - Cole of...

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Louis Bacon Is Having The Time Of His Life – Dealbreaker

Posted: May 9, 2020 at 9:50 am

When legendary hedge fund Louis Bacon returned his clients capital last year, possibly to avoid distraction from the destruction of his Bahamian neighbor and bte noire, he probably couldnt have known with certainty just how bad tings would get for Canadian discount fashion mogul Peter Nygard. Hed already seen their battle over tony Lyford Cay end in an arrest warrant for Nygard and the seizure of his impossibly garish and tasteless estate thereon. Since then, Bacons efforts to have Nygard exposed as a notorious sex criminal and human trafficker have exceeded beyond his wildest dreams: his company in bankruptcy and sold for parts; dozens of women alleging impossibly horrible assaults; and now a book to memorialize all of it and more.

Throughout the day, hed ask a particular girl if shed like to stay the night. If she said no? Ross alleged, Then theres always drugging. She even has alleged that Nygard went so far as to kill her family dog. The New York Times found that Nygard actually wired her $10,000 at one point, emailing Ross: I sent you money to buy a new dog..

I may be the only person in the world, he bragged, who has my own embryos growing in a petri dish.

One of his girlfriends, Suelyn Medeiros, wrote in her 2014 memoir about a trip she took with Nygard to Ukraine, where he was having stem cell research done.

He asked, Suelyn, do you know what the best stem cells are? she writes.

She did: Embryos.

Correct! she says Nygard responded. If you got pregnant and had an abortion, we could use those embryonic cells and have a lifes supply for all of us: you, your mother and me. A lot of people are doing it.

Well, if youre wondering just how much Bacon is enjoying all of this, why, take a look:

Billionaire investor Louis Bacons Moore Capital has gained 17 per cent so far this year, according to people familiar with the figures, which would rank it among the worlds best-performing hedge funds. Moores gains, which would rank among its biggest annual returns over the past decade, come as macro hedge funds enjoy a long-awaited revival.

Louis Bacons Moore Capital makes big gains after going it alone [FT]Fashion Mogul Peter Nygard Business Properties to Be Sold [WSJ]Canadian woman says fashion mogul Peter Nygard drugged and raped her in Bahamas [CBC]Inside the twisted world of rapist designer Peter Nygard: book [N.Y. Post]

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Louis Bacon Is Having The Time Of His Life - Dealbreaker

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Avalon GloboCare advancing immune cell therapy to treat blood cancers using FLASH-CAR technology – Proactive Investors USA & Canada

Posted: May 9, 2020 at 9:50 am

The adaptable FLASH-CAR platform can be used to create personalized cell therapy from a patients own cells, as well as off-the-shelf cell therapy from a universal donor

(NASDAQ: AVCO) announced Friday that it is advancing its next-generation immune cell therapy to treat blood cancers using FLASH-CAR technology co-developed with strategic partner Arbele Limited.

The adaptable FLASH-CAR platform can be used to create personalized cell therapy from a patients own cells, as well as off-the-shelf cell therapy from a universal donor.

Currently, the Chimeric Antigen Receptor T (CAR-T) cellular immunotherapy platform is available. It involves a patients own T-cells a type of white blood cell that protects against infections and other diseases including cancer that are turned into personalized cancer-fighting cells.

The T-cells are removed from the patient, reprogrammed in the lab using a viral vector to target cancer cells, and infused back into the patient as a cancer immunotherapy.

But in contrast to these existing therapies, Avalon said its FLASH-CAR platform uses next-generation CAR technology to modify patients T-cells and natural killer (NK) cells using a ribonucleic acid (RNA)-based platform rather than a viral vector.

Similar to T-cells, NK cells are a type of white blood cell, also able to attack cancer cells, but utilize different mechanisms. By using RNA molecules rather than a viral vector, Avalons RNA-based CAR technology is designed to rapidly create personalized CAR therapies in 1 to 2 days compared to the 10- to 14-day bio-manufacturing time necessary to generate currently available CAR-T cellular immunotherapy.

Avalon said its FLASH-CAR technology is also designed to reprogram the immune cells to hone in on multiple crucial cancer cell targets, called tumor antigens, to potentially achieve superior therapeutic effect. Avoiding the use of viral vectors and complicated bio-processing procedures significantly reduces manufacturing costs, resulting in a more affordable and potentially breakthrough therapy for cancer patients.

The FLASH-CAR technology can also be used to generate off-the-shelf,universal cell therapy that has the potential to reach even more patients.

Avalons first FLASH-CAR platform candidate, AVA-011, targets both CD19 and CD22 tumor antigens on cancer cells.

Pre-clinical research on AVA-011, including tumor cytotoxicity studies, has been successfully completed and Avalon said it is immediately entering the process development stage to generate clinical-grade CAR-T and CAR-NK cells for use in human clinical trials.

Avalon and Arbele have jointly filed for US patents for this RNA-based CAR platform cellular therapy and for other applications.

Avalon expects to begin a first-in-human clinical trial with AVA-011 for the treatment of relapsed or refractory B-cell lymphoblastic leukemia (B-ALL) and non-Hodgkin lymphoma in the first quarter of 2021. The goal is to use AVA-011 as a bridge to bone marrow stem cell transplant therapy, currently the only curative approach for patients with these blood cancers.

Avalon GloboCare is committed to decreasing the time it takes to deliver cellular immunotherapies to cancer patients, as well as lowering the cost of manufacturing by building on our unique RNA-based CAR platform that does not require using a viral vector, said CEO Dr David Jin.

We are accelerating our innovative discovery and development plan, as well as delivering precise clinical execution and leadership in cellular immunotherapy. Our pre-clinical studies are encouraging and we are excited for AVA-011 to enter the clinical development stage, including multi-center clinical trials following completion of process development to generate the cell therapy.

Arbele CEO John Luk added: Through this strategic partnership with Avalon GloboCare, we envision an accelerated scientific and clinical development of the RNA-based FLASH-CAR technology platform with great potential to generate 'off-the-shelf'immune effector cell therapies to treat both hematologic and solid malignancies.

Avalon, based in Freehold, New Jersey, specializes in developing cell-based technologies and is involved in the management of stem-cell banks and clinical laboratories.

The companys stock recently traded up 10% to $1.99a share in New York.

--UPDATES stock price--

Contact the author: [emailprotected]

Follow him on Twitter @PatrickMGraham

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Avalon GloboCare advancing immune cell therapy to treat blood cancers using FLASH-CAR technology - Proactive Investors USA & Canada

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Stemline Slated for Acquisition by Menarini in Deal Worth Up to $677M – Xconomy

Posted: May 9, 2020 at 9:50 am

XconomyNew York

Stemline Therapeutics, whose drug for a rare, aggressive type of acute leukemia was approved by the FDA about 18 months ago, has signed an acquisition deal with Italian biopharma Menarini Group.

Stemline (NASDAQ: STML), a New York-based company, developed the first FDA-approved drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN. The drug, tagraxofusp (Elzonris) targets CD123, a cell surface protein associated with the blood cancer.

The Menarini transaction is worth up to $677 million, according to the companies, which announced the agreement Monday. Under the deal terms Menarini, which is headquartered in Florence, plans to acquire Stemline shares at $12.50 apiece, split into $11.50 up front and another $1 upon the first sale of its drug in France, Germany, Italy, Spain or the United Kingdom following approval by the European Commissionas long as it occurs on or before the end of 2021.

Stemline requested European regulators review the drug as a treatment for adult BPDCN patients in January 2019, according to its latest annual report.

US sales of the drug brought in $43.2 million in 2019, its first year on the market. That year the company reported a net loss of $76.8 million.

Menarini CEO Elcin Barker Ergun, in a statement, said the acquisition would expand the Italian companys presence in the US and strengthen its oncology portfolio. The privately held biopharma says its annual sales top $4.2 billion.

As part of the Italian drug maker, Stemline plans to continue its efforts to launch the BPDCN drug outside of the US and to advance it as a potential treatment for other diseases. Stemline is also evaluating the drug in Phase 1/2 trials as a treatment for patients with chronic myelomonocytic leukemia, myelofibrosis, and acute myeloid leukemia.

Stemline saw its stock price soar on the acquisition announcement, rising to $12.10 in a jump of more than 150 percent compared to its close at $4.75 per share Friday. When Stemline went public in 2013, it priced its shares at $10 apiece.

Founded in 2003 by current CEO Ivan Bergstein, the companys approach to drug development is based on research into what are known as cancer stem cells, or cancerous cells that act like stem cells in that they reproduce themselves and sustain the cancer, showing outsize ability to resist chemotherapy and other standard cancer treatments. Read more about Stemlines origins in this Xconomy piece from 2011.

Both companies boards of directors have OKd the tie-up. If shareholders agree, the firms anticipate the deal will close this quarter.

Image: iStock/ChiccoDodiFC

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn for The European Union – GlobeNewswire

Posted: May 9, 2020 at 9:50 am

NEW YORK, N.Y., and TEL AVIV, Israel, May 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today a lease agreement with the Tel Aviv Sourasky Medical Center (Sourasky)in Tel Aviv, Israel, to produce NurOwn in three state-of-the-art cleanrooms. The new facility will significantly increase the Companys capacity to manufacture and ship its product into the European Union and the local Israeli market. The cleanroom facility is part of Souraskys Institute for Advanced Cellular Therapies.

"Sourasky Hospital is a leader in the advancement and manufacturing of cell and gene therapy products and is well-equipped to rapidly scale up and produce NurOwn," stated Prof. Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We look forward to continuing our work with BrainStorm to bring NurOwn to ALS patients and help fulfill the clinical therapy demands for the Companys pipeline programs.

"Sourasky Hospital, known for introducing pioneering solutions into clinical practice and advancing patient care, has a first rate team with the proven experience to produce regenerative products in accordance to the highest standard of cGMP manufacturing," said Chaim Lebovits, CEO of BrainStorm. "This agreement will ensure that we can provide NurOwn to patients after regulatory approval, not only in Israel but we have secured capacity to rapidly scale up production as we advance our investigational treatment across the European Union. We are very pleased to be able to expand our ongoing collaboration with Sourasky Hospital, one of the worlds most innovative and respected medical centers."

About NurOwn NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: + 1.862.397.1860pshah@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839sean.leous@icrinc.com

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Two New Research Institutes in the Bay Area – PRNewswire

Posted: May 9, 2020 at 9:50 am

The two institutes are an evolution of the former Gladstone Institute of Virology and Immunology, which was led by Warner Greene, MD, PhD, since its establishment in 1991 and made significant contributions to the fight against HIV/AIDS.

"As the joint Gladstone-UCSF search committee met with eminent scientists from around the globe to find a new director for the Gladstone Institute of Virology and Immunology, Melanie and Alex stood out as exceptional candidates in terms of their research accomplishments and their scientific vision," says Gladstone President Deepak Srivastava, MD, who chaired the search committee. "We realized they represent complementary, rather than alternative, directions for the future of Gladstone."

"They are both remarkable scientists," he adds. "We are honored to have them join our scientific leadership team and we look forward to the discoveries that will emerge from these new institutes."

The Gladstone Institute of Virology will focus on how viruses interface with human host cells to cause disease and how to intervene in that process. Ott's goal is to identify critical pathways that are common to human pathogenic viruses as a way to develop innovative treatments.

"Contrary to the current strategy of combining several drugs to treat one virus, we want to develop one drug against multiple viruses," says Ott, senior investigator at Gladstone and professor in the UCSF Department of Medicine. "As antibiotic resistance becomes an increasingly urgent problem, we will also delve into how we can use viruses as therapeutics, which involves using viruses against themselves or to fight bacteria."

Ott and her colleagues in the institute are concentrating their immediate efforts on the study of SARS-CoV-2, the virus that causes COVID-19. This work will continue to contribute important insights into the current pandemic through the development of rapid diagnostic, prevention, and treatment strategies, as well as help be better prepared for future coronavirus outbreaks and other emerging infections.

The Gladstone-UCSF Institute of Genomic Immunology will combine cutting-edge genomic technologies with gene editing and synthetic biology to better understand the genetic control of human immune cells and develop novel cell-based immunotherapies. Manipulation of the immune system holds great promise not only to treat cancer, but also for infectious diseases, autoimmune diseases, and maybe even neurologic conditions such as Alzheimer's disease.

"These rapidly advancing fields are starting to converge in ways that are too big for any single lab to take on," says Marson, senior investigator at Gladstone and associate professor in the Departments of Medicine and Microbiology and Immunology at the UCSF School of Medicine. "The impetus to start a new institute was the realization that we need to create an ecosystem to bring together people with different perspectives to think about transformative opportunities for how patients can be treated in the future."

Marson's institute will have lab space at Gladstone, adjacent to UCSF's Mission Bay campus, as well as at the University's Parnassus Heights campus, creating a unified community across the two campuses.

"The importance of pursuing advances in virology and immunology for human health has never been more clear, and we at UCSF applaud Gladstone's visionary leadership in establishing these two new institutes," says UCSF Chancellor Sam Hawgood, MBBS. "Under Melanie and Alex's excellent leadership, these research institutesincluding the first-ever Gladstone-UCSF institutewill complement and enhance UCSF's strengths in immunology and cell therapy, and will build on Gladstone's established expertise in the host-pathogen interface and gene editing technologies. Our long-standing partnership leverages the best of both institutions."

About the Search Committee

The joint Gladstone-UCSF search committee that recruited Melanie Ott and Alexander Marson was chaired byDeepak Srivastava. Other members included Katerina Akassoglou, Warner Greene, Todd McDevitt, Katherine Pollard, and Leor Weinberger from Gladstone, as well as Max Krummel, Susan Lynch, Tiffany Scharschmidt, Anita Sil, and Julie Zikherman from UCSF.

About Melanie Ott

A native of Germany, Melanie Ott, MD, PhD,is the director of the Gladstone Institute of Virology, a senior investigator at Gladstone Institutes, and a professor of medicine at UCSF.

Ott is passionate about using viruses to find fundamental new biology in host cells. She has made important discoveries about how virusesincluding the hepatitis C virus and Zikahijack human cells, and has contributed to efforts to eradicate HIV by gaining insight into viral transcriptional control. Since the outbreak of the COVID-19 pandemic, she pivoted the focus of her team and spearheaded the effort to establish a dedicated airborne pathogen BSL-3 lab to enable work on live SARS-CoV-2.

Prior to joining Gladstone in 2002, Ott started her own research group at the German Cancer Research Center in Heidelberg, Germany, working closely with Nobel laureate Harald zur Hausen. She is a trained neurologist with an MD from the University of Frankfurt/Main in Germany. She transitioned to basic virology research during the AIDS crisis, earning a PhD in molecular medicine from the Elmezzi Graduate School in Manhasset, New York.

Ott has received several honors, including the Young Researcher Award at the European Conference on Experimental AIDS Research and the Hellman Award. She is a member of the Association of American Physicians and a Fellow of the American Academy of Microbiology. She is a recipient of the Chancellor's Award for Public Service from UCSF for her work as the founder and co-chair of the student outreach committee at Gladstone. Ott also received the California Life Sciences Association's Biotechnology Educator Pantheon Award for establishing thePUMAS (Promoting Underrepresented Minorities Advancing in the Sciences) internship programat Gladstone, which seeks to increase diversity in STEM.

About Alexander Marson

Alexander Marson, MD, PhD,is the director of the Gladstone-UCSF Institute of Genomic Immunology, a senior investigator at Gladstone Institutes, and an associate professor in the Departments of Medicine and Microbiology and Immunology at UCSF.

Marson is interested in how DNA controls the behavior of cells in the human immune system. He uses the power of CRISPR technology to genetically engineer cells to fight cancer, autoimmune diseases, and infectious diseases.

He completed his undergraduate studies at Harvard University, and earned an MPhil in biological sciencesfromCambridge. He earned his PhD at Whitehead Institute at MIT, where he worked with mentors Rick Young and Rudolf Jaenisch on transcriptional control of regulatory T cells and embryonic stem cells.

After completing his MD at Harvard Medical School and an internship and residency at the Brigham and Women's Hospital, Marson joined UCSF in 2012 to complete clinical work as an infectious diseases fellow. He started his lab as a Sandler Faculty Fellow, before joining the faculty at UCSF and becoming scientific director of biomedicine at the Innovative Genomics Institute. He is also a Chan Zuckerberg Biohub Investigator and member of the Parker Institute for Cancer Immunotherapy.

About Gladstone Institutes

To ensure our work does the greatest good, Gladstone Institutes focuses on conditions with profound medical, economic, and social impactunsolved diseases. Gladstone is an independent, nonprofit life science research organization that uses visionary science and technology to overcome disease. It has an academic affiliation with the University of California, San Francisco.

About UCSF

The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.UCSF Health, which serves as UCSF's primary academic medical center,includestop-ranked specialty hospitalsand other clinical programs, and has affiliations throughout the Bay Area. Learn more atucsf.edu, or see ourFact Sheet.

Sources

Gladstone Institutes: Megan McDevitt | [emailprotected] | 415.734.2019

UCSF: Pete Farley |[emailprotected] | 415.502.4608

SOURCE Gladstone Institutes

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