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Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome…

Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite

"Novellus's iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of their high potency as demonstrated in our pre-clinical studies, as well as our ability to cost-effectively provide high doses and repeat doses." said Myron Holubiak, CEO of Citius.

"We are excited to be developing iMSCs because of their promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19," said Matt Angel, Chief Science Officer of Novellus. He continued, "Our iMSCs have multimodal immunomodulatory mechanisms of action that make them promising for treatment of acute respiratory diseases."

About Novellus Therapeutics LimitedNovellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its patented non-immunogenic mRNA, high-specificity gene editing, mutation-free & footprint-free cell reprogramming and serum-insensitive mRNA lipid delivery technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellustx.com.

About NoveCite, Inc.NoveCite, Inc. is a newly formed subsidiary of Citius Pharmaceuticals, a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

Contact: [emailprotected]

SOURCE Novellus Therapeutics

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Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome...

Manufacturing a Personalized Cellular Universe: 3D Bioprinting in the Biotech Industry – BioSpace

Tissues in the body work as a complex team of interconnected cells. For instance, the heart is comprised of contractile cardiomyocytes, along with a vast array of endothelial cells, immune cells and fibroblasts. Similarly, the liver includes hepatocytes, immune cells, endothelial cells and epithelial cells. Put in all the cellular players, and the team wins. Take out one player, and the team is no longer able to sufficiently function.

The field of 3D bioprinting draws deeply on this idea of optimizing tissue regeneration and replacement. By using naturally-derived scaffolds, human cells and other biocompatible materials, 3D bioprinting has ushered in opportunities for researchers to design, print and optimize patient personalized tissues for purposes ranging from transplantation to drug testing.

The current drug development process is extremely lengthy and costly due to the lack of proper tools for preclinical drug screening, said Dr. Wei Zhu, CEO of Allegro 3D, a San Diego-based bioprinting company. What excites us most about 3D bioprinting is its potential to provide a paradigm shift in the drug discovery and screening process.

The bioprinting process is analogous to a Build-A-Bear factory but while a teddy bear contains carefully chosen ribbons, buttons and stuffing, 3D bioprinting creates complex tissues possibly derived from a patients own cells. In both cases, integrating customized components allows for layer-by-layer formation of something unique, yet fully functional.

While the techniques used for 3D bioprinting have mechanical grounding in traditional printing, the defining characteristic of 3D bioprinting is the usage of bioinks. Bioinks are complex, optimized mixtures of solution matrices containing carrier molecules and additional supporting agents. Often, the solution material is a biopolymer a naturally-derived gel, used to envelop the cells as a 3D molecular scaffold. Common biomaterials include gelatin, hyaluronic acid and alginate, all of which retain a high degree of biocompatibility. They provide a supporting structure, as well as a nurturing environment for future cellular growth and differentiation.

Historically, 3D bioprinting has become possible through three main modalities: light-based bioprinting, inkjet bioprinting and extrusion based bioprinting. Light-based bioprinting utilizes a light source, which can often be a blue LED, to cure photo-polymerizable bioinks into a more solidified scaffold. Inkjet bioprinting, on the other hand, is analogous to the conventional desktop printer, where bioink droplets are positioned on a receiving substrate based on computer control. Finally, extrusion based bioprinting relies on pressure to mechanically dispense bioinks by syringe extrusion onto receiving substrates.

Each technique has its own unique advantages. For example, light-based bioprinting allows for an incredible degree of precision, resolution and speed resulting in the possibility of micro or nanopatterning in a rapid fashion. Inkjet or droplet bioprinting is markedly straightforward, with low overall production costs and easy handling. Extrusion-based printing allows for printing with high cell densities.

Allegro 3D finds its niche in the bioprinting industry by providing light-based printing products primarily, their StemakerTMbioprinter and SteminkTMbioinks. Notably, the StemakerTMbioprinter was the worlds first digital light processing (DLP) bioprinter for high throughput tissue printing. Light is applied to the pre-polymer bioink, which photopolymerizes layer-by-layer to encapsulate live cells in the final 3D tissue construct. By using visible light as the photopolymerization source, cell viability remains very high during the manufacturing process. Furthermore, the technique allows for incorporation of various cell types in a single printed scaffold for instance, liver cells in the bottom layer, and endothelial cells in the top layer. With the ability to mix and match various cell types, the complexity and diversity of human tissues is an achievable possibility.

In terms of application, the possibilities of Allegro 3Ds bioprinting techniques have dramatic implications for the biomedical community.

With our StemakerTMbioprinters and SteminkTMbioinks, our customers can print 3D precision human tissues on demand for various biomedical applications, Zhu said. These applications include building tissue samples for disease modeling, providing patient-specific tissues or organs for therapeutic treatment of injuries, and providing 3D human tissues to investigate the toxicity and efficacy of new drug compounds in vitro.

By closely mimicking hepatic lobule structure through an eye-catching pattern of hexagons and circles that looks somewhat like a bees hive, this DLP bioprinter was able to print human liver tissue containing both human induced pluripotent derived stem cells and other supporting cells in seconds. The goal of such constructs would then be to provide easily accessible tissues for high-throughput drug discovery, or to print patient-derived hepatic tissues for liver regeneration.

According to Zhu, a key issue with traditional bioprinting techniques is that of scalability. Pharmaceutical and biotechnology industries often use high-throughput screening instruments for which the needs far exceed the capabilities of traditional bioprinters. The photopolymerization techniques of the StemakerTMbioprinter allow for compatibility with the high-throughput systems, which will greatly help our customers improve the accuracy and efficiency of drug screening and assay development.

On the extrusion-based bioprinting front, Allevi, a 3D bioprinting company based in Philadelphia, focuses on providing universally-friendly extrusion-based bioprinters, bioinks and software. Their latest model, named Allevi 3, contains three extruders through which bioinks can be deposited to form tissue scaffolds. Allevi also offers a wide selection of bioinks, which can be mixed in conjunction with cell populations to be directly utilized in their 3D bioprinters.

Likewise, Cellink, which was the first company to commercialize bioinks, is a Boston-based bioprinting company that has since expanded to provide services ranging from bioprinters to live cell imaging and liquid handling machines. Cellinks bioprinters include extrusion-based printers that contain up to six extruder heads with the BIO X6, as well as light-based printers. Their vast array of automated systems represents a diverse amalgamation of capabilities for more streamlined manufacturing.

Altogether, these 3D bioprinting companies represent a rapidly growing sector of the biotechnology industry. The unmet medical need of human tissue for regeneration, drug testing, and other pharmaceutical purposes remains a key driving force. 3D bioprinting has potential to change the ways in which we discover new, exciting chemical compounds to treat debilitating diseases, or to eliminate the strenuous waiting game experienced by many in need of an organ transplant. With the advent of these technologies, we acknowledge a future where we may potentially design, print and order complex human tissues for life-saving purposes.

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Manufacturing a Personalized Cellular Universe: 3D Bioprinting in the Biotech Industry - BioSpace

Global Stem Cell Therapy Market 2020: Trends, and Opportunity Analysis, Top Manufacturers And Forecast to 2027 – PRnews Leader

Reportspedia has recently come up with a new market research report titled, Stem Cell Therapy Market. This statistical market study compromises an extensive understanding of the present-day and impending stages of the industry market based on factors such as major research skills, management schemes, drivers, restraints, opportunities, challenges, and visions include the subdivisions in the industries and regional distribution. Besides, this report emphasizes the latest events such as technological developments and product launches and their consequences on the Market. The research report delivers the global market revenue, parent market trends along with market attractiveness per market segment.

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Top Key Players:

Celgene Corporation Osiris Therapeutics, Inc. Pharmicell Co., Ltd MEDIPOST Co., Ltd. Promethera Biosciences Fibrocell Science, Inc. Holostem Terapie Avanzate S.r.l. Cytori Therapeutics Nuvasive, Inc. RTI Surgical, Inc. Anterogen Co., Ltd. RTI Surgical, Inc

Regional Stem Cell Therapy Market (regional production, demand, and forecast by country):

The market specialists and researchers have done an all-encompassing breakdown of the global Stem Cell Therapy Market with the benefit of research methodologies such as PESTLE and Porters Five Forces analysis. They give precise and reliable market data and helpful recommendations with a means to support the players gain an insight into the overall current and upcoming market scenario. The report provides key statistics on the market status, size, share, growth factors of the Global Stem Cell Therapy industry.

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The main goals of the research report elegant the overall market overview on Stem Cell Therapy market dynamics, historic volume and value, newest and upcoming trends, Porters Five Forces Analysis, cost structure, government policies, and regulations, etc.

KEY MARKET SEGMENTS

On the basis of types, the Stem Cell Therapy Market is primarily split into:

Adult Stem Cells Human Embryonic Induced Pluripotent Stem Cells Very Small Embryonic Like Stem Cells

On the basis of applications, the Stem Cell Therapy Market covers:

Regenerative Medicine Drug Discovery and Development

This research report represents a 360-degree overview of the competitive landscape of the Meat Ingredients Market. Likewise, it offers enormous data relating to current trends, technological advancements, tools, and methodologies. The Stem Cell Therapy report thoroughly upholds the up-to-date state of dynamic segmentation of the Stem Cell Therapy Industry, highlighting major and revenue efficient market segments comprising the application, type, technology, and the like that together coin lucrative business returns in the Stem Cell Therapy market.

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Key Pointers of the Report:

Table of Contents

Global Stem Cell Therapy Market Research Report

Chapter 1 Stem Cell Therapy Market Overview

Chapter 2 Global Economic Impact on Stem Cell Therapy

Chapter 3 Global Stem Cell Therapy Market Competition by Key Players

Chapter 4 Global Production, Revenue (Value) by Region

Chapter 5 Global Stem Cell Therapy Industry Analysis by Application, Type

Chapter 6 Stem Cell Therapy Market Manufacturing Cost Analysis

Chapter 7 Marketing Strategy Analysis, Distributors/Traders

Chapter 9 Market Effect Factors Analysis

Chapter 9 Global Stem Cell Therapy Market Forecast

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https://www.reportspedia.com/report/business-services/2015-2027-global-stem-cell-therapy-industry-market-research-report,-segment-by-player,-type,-application,-marketing-channel,-and-region/57925#table_of_contents

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Global Stem Cell Therapy Market 2020: Trends, and Opportunity Analysis, Top Manufacturers And Forecast to 2027 - PRnews Leader

Fate Therapeutics Announces Presentations at the 2020 Society for Immunotherapy of Cancer Annual Meeting – GlobeNewswire

October 15, 2020 08:00 ET | Source: Fate Therapeutics, Inc.

SAN DIEGO, Oct. 15, 2020 (GLOBE NEWSWIRE) -- FateTherapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced that five abstracts for the Companys induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the Society for Immunotherapy of Cancer (SITC) annual meeting being held virtually from November 9-14, 2020.

Accepted abstracts include clinical data from 15 patients in the dose-escalation stage of the Companys Phase 1 clinical trial of FT500 in advanced solid tumors (NCT03841110), which includes nine patients in Regimen A (three once-weekly doses of FT500 for up to two 30-day cycles as monotherapy) and six patients in Regimen B (three once-weekly doses of FT500 for up to two 30-day cycles in combination with checkpoint inhibitor therapy). The Company is currently enrolling the dose-expansion stage of the Phase 1 clinical trial for patients with non-small cell lung cancer or classical Hodgkin lymphoma who are refractory to, or have relapsed on, checkpoint inhibitor therapy. Each patient in the dose-expansion stage is to receive three once-weekly doses of FT500 at 300 million cells per dose, each with IL-2 cytokine support, for up to two 30-day cycles in combination with the same checkpoint inhibitor on which the patient failed or relapsed.

Oral Presentation

Poster Presentations

All abstracts are scheduled to be available on the SITC website on November 9, 2020.

About Fate Therapeutics iPSC Product Platform The Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About FT500 FT500 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. The product candidate is being investigated in an open-label, multi-dose Phase 1 clinical trial for the treatment of advanced solid tumors (NCT03841110). The study is designed to assess the safety and tolerability of FT500 as a monotherapy and in combination with one of three FDA-approved immune checkpoint inhibitor (ICI) therapies nivolumab, pembrolizumab or atezolizumab in patients that have failed prior ICI therapy. Despite the clinical benefit conferred by approved ICI therapy against a variety of tumor types, these therapies are not curative and, in most cases, patients either fail to respond or their disease progresses on these agents. One common mechanism of resistance to ICI therapy is associated with loss-of-function mutations in genes critical for antigen presentation. A potential strategy to overcome resistance is through the administration of allogeneic NK cells, which have the inherent capability to recognize and directly kill tumor cells with these mutations.

About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of, plans related to, and the therapeutic potential of the Company's product candidates, the Companys clinical development strategy and plans for the clinical investigation of its product candidates, and the Companys preclinical research and development programs. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk of difficulties or delay in the initiation of any planned clinical studies, or in the enrollment or evaluation of subjects in any future clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that results observed in preclinical studies of the Companys product candidates may not be replicated in ongoing or future clinical trials or studies, and the risk that the Companys product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

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Fate Therapeutics Announces Presentations at the 2020 Society for Immunotherapy of Cancer Annual Meeting - GlobeNewswire

World Wide Stem Cell Treatment Centers Provides Exceptional Regenerative Treatment Options To Those in Need – GlobeNewswire

October 16, 2020 12:00 ET | Source: World Wide Stem Cell Treatment Centers

PITTSBURGH, Oct. 16, 2020 (GLOBE NEWSWIRE) -- Those who are looking for an alternative treatment option when compared to traditional medicine are now in luck. Recently, World Wide Stem Cell Treatment Centers announced that it was opening the first of its more than 300 planned locations all over the world. With access to a wide range of treatment options, it is possible for patients to visit World Wide Stem Cell Treatment Centers and enjoy a more comprehensive recovery process than they ever have in the past. Therefore, it is important to highlight some of the major benefits that come with visiting World Wide Stem Cell Treatment Centers or health treatment options.

An Introduction to World Wide Stem Cell Treatment Centers: The First Location is Open

Right now, the first location has opened for World Wide Stem Cell. This treatment center location is in Pittsburgh, Pennsylvania. Currently, more than 300 locations are scheduled to open worldwide.

In many situations, treatment options from World Wide Stem Cell can actually work very well when working in combination with traditional medical therapy. The goal of World Wide Stem Cell Treatment Centers is to provide patients with more options, allowing them to tailor their treatment options to meet their individual needs and avoid invasive surgery whenever possible. In this manner, patients can work with the professionals at World Wide Stem Cell to develop a custom treatment plan to meet their unique needs.

Who Might Need Stem Cell Therapy from World Wide Stem Cell Treatment Centers?

The reality is that anyone is able to benefit from stem cell therapy from World Wide Stem Cell. At the same time, it is also important for people to know what goes into stem cell therapy.

First, one of the most common patient populations that might benefit from a visit to World Wide Stem Cell is athletes who have suffered an injury. While participating in their sport. While sports are great for conditioning and staying in shape. Injuries are always a very real risk. When an athlete suffers an injury, World Wide Stem Cell is able to treat that athlete and in most cases have that athlete participating back in his sport again in up to 1/10th of the time without invasive surgery. So with that being said the entire population at one time or another are candidates for stem cells. Whether it be a knee, hip, shoulder or any other orthopedic joint. Stem cells in most cases are able to replace invasive surgery; with a stem cell injection. World Wide Stem Cell always treats every condition with the proper cells for that particular situation. We only use orthopedic surgeons and neurosurgeons that do all our injections and they are all done with ultrasound guided needle injections. Whether you are interested in orthopedic treatments, facial rejuvenation, anti-aging cells, hair replacement, erectile dysfunction. We have them all at World Wide Stem Cell. Call, email, inquire!

Contact:

300 Chapel Harbor Drive Suite 204 Pittsburgh, Pa 15238 Contact: JS Genslinger (founder) 412-408-3183

World Wide Stem Cell Treatment Centers

Pittsburgh, Pennsylvania, UNITED STATES

Formats available:

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World Wide Stem Cell Treatment Centers Provides Exceptional Regenerative Treatment Options To Those in Need - GlobeNewswire

BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update – PRNewswire

NEW YORK, Oct. 15, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the third quarter ended September 30, 2020, and provided a corporate update.

"The most important near-term event for BrainStorm will be the upcoming top-line data readout for the NurOwn Phase 3 trial in ALS, expected by the end of November. A successful outcome will set us on the path to filing a Biologic License Application (BLA) for what we believe will be a valuable new treatment for ALS," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "In parallel to our preparations for upcoming data read out, we are very busy planning and executing on other pre-BLA activities. On the management front, we appointed William K. White and Dr. Anthony Waclawski, adding valuable commercial and regulatory expertise to our leadership team. This expertise will be crucial as we work towards obtaining regulatory approval for NurOwn and ensuring that, if approved, it will be readily accessible to ALS patients in need of new treatment options for this devastating disease."

NurOwn has an innovative mechanism of action that is broadly applicable across neurodegenerative diseases and BrainStorm continues to invest in clinical trials evaluating the product in conditions beyond ALS to maximize value creation for its various stakeholders. The company remains on track to complete dosing in its Phase 2 clinical trial in progressive multiple sclerosis (PMS) by the end of 2020. In addition, the Company recently unveiled a clinical development program in Alzheimer's' disease (AD) and is planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France.

Third Quarter 2020 and Recent Corporate Highlights:

Presented at the following Investor Conferences:

Cash and Liquidity as of October 14, 2020

Total available funding as of October 14, 2020, which includes cash, cash equivalents and short-term bank deposits of approximately $33.1 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $36 million.

Financial Results for the Three Months Ended September 30, 2020

Conference Call & WebcastThursday, October 15, 2020 at 8 a.m. Eastern TimeFrom the US:877-407-9205 International: 201-689-8054 Webcast:https://www.webcaster4.com/Webcast/Page/2354/37811

Replays, available through October 29, 2020 From the US:877-481-4010 International: 919-882-2331 Replay Passcode: 37811

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 (NTFs). 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 acceptance from theU.S. Food and Drug Administration(FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and completed enrollment inAugust 2020.

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 theU.S. Food and Drug Administration(FDA) and theEuropean Medicines Agency(EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at sixU.S.sites supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a filing forU.S.FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently receivedU.S.FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment inAugust 2020. For more information, visit the company's website atwww.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 cause BrainStorm Cell Therapeutics Inc.'s actual 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, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's 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 BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's 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.

ContactsInvestor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 [emailprotected]

Media:Paul Tyahla SmithSolve Phone: + 1.973.713.3768 [emailprotected]

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data)

September30,

December31,

2020

2019

U.S.$ inthousands

Unaudited

Audited

ASSETS

Current Assets:

Cash and cash equivalents

$

24,770

$

536

Short-term deposit (Note 4)

4,038

33

Other accounts receivable

1,473

2,359

Prepaid expenses and other current assets (Note 5)

56

432

Total current assets

30,337

3,360

Long-Term Assets:

Prepaid expenses and other long-term assets

27

32

Operating lease right of use asset (Note 6)

1,377

2,182

Property and Equipment, Net

950

960

Total Long-Term Assets

2,354

3,174

Total assets

$

32,691

$

6,534

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

Current Liabilities:

Accounts payable

$

3,283

$

14,677

Accrued expenses

917

1,000

Operating lease liability (Note 6)

1,216

1,263

Other accounts payable

1,013

714

Total current liabilities

6,429

17,654

Long-Term Liabilities:

Operating lease liability (Note 6)

284

1,103

Total long-term liabilities

284

1,103

Total liabilities

$

6,713

$

18,757

Stockholders' Equity (deficit):

Stock capital: (Note 7)

12

11

Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 31,567,592 and 23,174,228 shares at September 30,2020 and December31,2019 respectively.

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BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update - PRNewswire

Proposition 14: Stem cell research bonds City Times – City Times

New bonds would continue to fund an existing institute

Brandon Manus

California is voting on selling $5.5 billion in new bonds for research and development of stem cell research. Graphic by Brandon Manus

Brandon Manus, Staff Writer October 15, 2020

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California is voting on selling $5.5 billion in new bonds to continue funding grants for research and development of stem cell treatments.

A yes vote on this measure means Proposition 14 would issue $5.5 billion in funding to an existing state stem cell research institute. The California Institute for Regenerative Medicine, based in Oakland, was created in a 2004 voter-approved measure to support scientific research toward finding treatments and a deeper understanding of diseases such as Alzheimers, heart disease, cancer and strokes. Voters originally approved $3 billion, but that money is now on its last legs. As of June 2020, only $30 million remained.

A no vote on this measure means the state could not sell $5.5 billion in bonds primarily for stem cell research and the development of new medical treatments in California. Some opponents say the institute hasnt produced the kind of life-saving treatments that were promised when it was created. There is also no longer a ban on federal funding for stem cell research, which led to the institutes creation in 2004. The institute is funded with public money, but does not have any legislative oversight or address potential conflicts of interest. Some opponents have also criticized the requirement that $1.5 billion be cordoned off for brain and central nervous system diseases, saying it hampers the institutes flexibility to respond to changing needs.

Vote No on Prop. 14, a costly, unnecessary bond measure, The Sun (article) Stem-cell agency doesnt merit additional funding, The Mercury News (article)Why Prop. 14 is unaffordable, unnecessary, fatally flawed and unsupportable, The San Diego Union-Tribune (article) What Proposition 14 Tells Us About California, The New York Times (article) More borrowing for stem cell research, Los Angeles Times (article)

Californians for Stem Cell Research California Democratic Party Juvenile Diabetes Research Foundation University of California Board of Regents Californians For Stem Cell Research

Marcy Darnovsky, executive director of the Center for Genetics and Society

For more information about Prop 14, go to Ballotpedia.org.

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Proposition 14: Stem cell research bonds City Times - City Times

How a UCSF team is giving Cronutt the sea lion a second chance with neuroscience – University of California

A cellular therapy for epilepsy developed at UC San Francisco has been employed for the first time in a sea lion with intractable seizures caused by ingesting toxins from algal blooms. The procedure is the first-ever attempt to treat naturally occurring epilepsy in any animal using transplanted cells.

The 7-year-old male sea lion, named Cronutt, first beached in San Luis Obispo County in 2017 and was rescued byThe Marine Mammal Center(TMMC), based in Sausalito, Calif. His epilepsy is due to brain damage caused by exposure to domoic acid released bytoxic algal blooms. Each year, domoic acid poisoning affects hundreds of marine mammals, including both sea lions and sea otters, up and down the West Coast, a problem that is on the rise as climate change warms the worlds oceans, making algal blooms more common.

Like many of these animals, Cronutt cannot survive in the wild due to his epilepsy, and he was transferred by TMMC in 2018 to Six Flags Discovery Kingdom in Vallejo, Calif., which has facilities to care for wildlife with special veterinary needs.

In recent months, Cronutts health has declined due to increasingly frequent and severe seizures. With all other options exhausted, his veterinary team sought help from epilepsy researcherScott C. Baraban, Ph.D., in a last-ditch effort to save the sea lions life. For over a decade, Baraban, who holds the William K. Bowes Endowed Chair in Neuroscience Research in UCSFsDepartment of Neurological Surgery, has been developing the cell-based therapy, which has been shown by his research team to be highly effective in experimental lab animals.

This method is incredibly reliable in mice, but this is the first time it has been tried in a large mammal as a therapy, so well just have to wait and see, said Baraban, a member of the UCSF Weill Institute for Neurosciences. Over the years Ive come to learn how many marine mammals cant be released into the wild due to domoic acid poisoning, and its our hope is that if this procedure is successful it will open the door to helping many more animals.

On Tuesday, Oct. 6, a team of 18 specialists, including veterinarians from Six Flags and neurosurgeons and researchers from UCSF, successfully completed a precisely targeted injection of brain cell precursors taken from pig embryos called neural progenitor cells into Cronutts hippocampus, the brain region responsible for seizures. Based on extensive observations in rodents, Baraban said, the injected embryonic cells should migrate through his damaged hippocampus over the course of days and weeks, integrating and repairing the brain circuitry causing his seizures.

It was a remarkable convergence. Every year there are many animals suffering from epilepsy for which there isnt any treatment available, while, just across the bridge from The Marine Mammal Center, we at UCSF are trying to develop this new form of therapy and looking for ways to one day translate it to the clinic, saidMariana Casalia, Ph.D., a postdoctoral researcher who joined Barabans lab in 2015 to work ontranslating the groups successes in rodentsinto therapies, and who has taken the helm of the sea lion epilepsy project. It seemed very natural for us that these animals could be first patients to hopefully benefit from this therapy.

Domoic acid poisoning in marine mammals causes hippocampal damage very similar to that seen in temporal lobe epilepsy, the most common form of epilepsy in humans. In this disease, damage to hippocampal inhibitory interneurons removes the brakes on electrical activity, leading to seizures. In a vicious cycle, seizures can further damage brain circuitry, which is why epilepsy often worsens over time.

Since 2009, theBaraban labhas been developing a way to replace these damaged interneuronsby transplanting embryonic MGE (medial ganglionic eminence) progenitor cells into the hippocampus. As discovered two decades ago by Barabans UCSF colleaguesArturo lvarez-Buylla, Ph.D., andJohn Rubenstein, Ph.D., MGE cells normallymigrate into hippocampus during brain developmentandintegrate themselves into the local circuitry as inhibitory neurons.

Barabans group has shown that its possible to transplant embryonic MGE cells into the brains of adult rodents with temporal lobe epilepsy, wherethey quickly spread through the hippocampus and repair its damaged circuitry. The procedure reliably reduces seizures in these animals by 90 percent, along with other side effects of epilepsy, such as anxiety and memory problems.

Our laboratorys work has been inspired by the desire to find new solutions for the 30 percent of temporal lobe epilepsy patients who dont respond to available drug treatments, and for whom no new medicines have emerged over the past 50 years. Baraban said. For a number of reasons, including regulatory hurdles, cellular therapies for people with epilepsy are probably still a long way off. However, marine mammals with brain damage from domoic acid poisoning are in a very similar boat with no effective treatments that would let them ever be returned to the wild.

Baraban learned about the hundreds of annual domoic acidrelated strandings of marine mammals from long-time colleague Paul Buckmaster, D.V.M., Ph.D., of Stanford University. Buckmasters seminal studies in collaboration with TMMC in Sausalito had found that these animalssuffer from hippocampal damage almost identical to human temporal lobe epilepsy.

As soon as Mariana and I learned about this issue it was clear that our approach could be a perfect solution to help rehabilitate these animals, Baraban said.

Casalia had spent four years developing and testing a pig source of MGE cells pig tissue is often used for transplants into humans in collaboration with colleagues at UC Davis, work the lab intends to publish soon. On learning about the plight of domoic acidpoisoned sea lions, she partnered with TMMC and the California Academy of Sciences to study sea lion skulls to begin planning an eventual transplant surgery. She ultimately worked with UCSF neurosurgery chairEdward Chang, M.D., and collaborators at the medical software firmBrainLabto create a custom targeting system for the sea lion brain.She had even spent months working closely with the Hamilton Company to create a custom needle for delivering the stem cells to the right spot in a sea lions hippocampus.

All that remained was to find the right patient. And then, in September, 2020, they got a call from a veterinarian at Six Flags asking if they could help save the life of a sea lion named Cronutt.

After rescuing Cronutt in 2017, TMMC had attempted three times to rehabilitate him and release him back into the wild. Each time he would beach himself again, emaciated, disoriented, and approaching humans. Then he began to have seizures. Most marine centers dont have facilities for the long-term care of marine mammals with special needs, but Six Flags volunteered to give Cronutt a new home.

We have cared for a lot of special needs animals over the years, said Dianne Cameron, director of animal care at Six Flags. We adore Cronutt and are committed to providing him a forever home. He has his own apartment in our Sea Lion Stadium with a pool and dry resting area. When hes doing well, he comes out and participates in training sessions. Unfortunately, recently it has been hard to get him to come out of his apartment.

Over this spring and summer, Cronutt had begun a serious decline his seizures were increasing, he was losing weight, and he often seemed disoriented. To oversee Cronutts care, Six Flags hiredClaire Simeone, DVM, a founder and CEO of Sea Change Health, who hadstudied the neurological effects of domoic acid poisoningduring her six years working with TMMC. But it soon became clear that no treatment was working for Cronutt.

Despite our best efforts and all the tools that we have, his seizures were becoming more prolonged and more frequent over time, Simeone said. His brain damage and the effects on his body were getting worse. His decline has been gradual, but we reached a point several months ago where we were questioning what quality of life he had. We had run out of options for how we could successfully manage Cronutts disease and knew that we were going to have to make some hard decisions soon.

Then Simeone recalled a talk Baraban had given at TMMC several years ago about the potential of MGE transplants for marine mammals with domoic acid poisoning. In September, she reached out to ask if the lab might be willing to attempt the procedure as a last-ditch effort to save Cronutts life.

Cronutts health was slipping fast, but Casalias years of preparation for this moment allowed her and her colleagues to quickly assemble everything that would be needed in just one month.

In a bit of serendipity that would prove crucial, Cronutts brain had already been imaged in 2018 by Ben Inglis, Ph.D., of UC BerkeleysHenry H. Wheeler Jr. Brain Imaging Centeras part of an ongoing study ofhow domoic acid poisoning affects the sea lion brain. These MRI images provided critical guideposts that made it possible for UCSF neurosurgeons to plan how they would inject stem cells at just the right spot in Cronutts hippocampus.

Cronutts surgery, conducted in accordance with COVID-19 protocols at the SAGE Veterinary Centers in Redwood City, Calif., went smoothly, and he was returned to Six Flags. In the days after the surgery his veterinary team reported that he had been sleeping and eating well.

Based on prior experiments transplanting pig MGE cells into rats, the researchers expect it to take about a month or so for the cells to fully integrate into Cronutts hippocampus. They will be following up to see if his seizures decrease and his health and behavior improves, and whether his antiseizure medications can be reduced.

This first-ever attempt has been made possible by funding from a Javits Award from the National Institutes of Health and from the UCSFProgram in Breakthrough Biomedical Research. Without these funds, this kind of high-risk, high-reward science would never have gotten off the ground, Baraban added. It also depended on Marianas fearlessness and perseverance in pursuing this very uncertain project.

Casalia, who has degrees in applied science and neurobiology from Universidad National de Quilmes and the University of Buenos Aires in Argentina, says the surgery felt like a culmination of everything shed been working on in her career so far. Ive always wanted to apply what we are doing in the lab to the clinical setting, she said. For me the ability to do this in reality to help these animals who are suffering is a dream come true.

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How a UCSF team is giving Cronutt the sea lion a second chance with neuroscience - University of California

Months after achieving unicorn status, Orca steers into the fast lane with an RMAT designation for cell therapy candidate – Endpoints News

A few months after its last big catch a $192 million Series D and rare unicorn status Orca Bio has reeled in the FDAs regenerative medicine advanced therapy (RMAT) designation for its experimental cell therapy to treat blood stem cell transplant patients.

Orca, one of this years Endpoints 11 startups, was founded by three entrepreneurs who were intrigued by Irv Weissmans cell purification work while studying at Stanford. Novartis then Sandoz had purchased Weissmans spinout SyStemix in the 90s, then scrapped it due to practical challenges. But Jeroen Bekaert, Ivan Dimov and Nate Fernhoff saw potential there.

Now, the biotech has RMAT and orphan drug designation to steer its cell therapy candidate Orca-T through the clinic. RMAT designation comes with the benefits of both fast track and breakthrough therapy designations.Orca-T entered a Phase I/II trial in patients undergoing stem cell transplants for various blood cancers last November, according to an NIH filing. The biotech expects to read out data from that trial this December at the annual American Society of Hematology meeting.

The RMAT and ODD for Orca-T is uplifting news for patients with various blood cancers including acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndrome and myelofibrosis, Dimov said in a statement.

While a hematopoietic stem cell transplant is the best option for some patients with blood cancer, the procedure can lead to dangerous complications, such as graft-versus-host disease, in which immune cells from the donor attack the patients healthy cells. Orca-T is designed to reprogram the diseased blood system, by matchinga specific composition of stem and immune cells to the immunological needs of a patient.

Orcas recent Series D brought its total raise to about $300 million, and came in as the companys valuation surpassed $1 billion. Plus, the biotech touts Weissman, former Novartis CEO Joe Jimenez, and Lyell head and former NCI chief Rick Klausner as its advisors.

Dimov spoke with Endpoints Newslast month about the inspiration behind the biotechs 2016 launch:

It almost seems unethical from a human perspective because some of the initial results suggest highly curative effects and the whole thing was shut down for over a decade because of some of these challenges of practically implementing these things and deploying them. So that was sort of the key driver for us to get started. And we always knew we wanted to fulfill that dream all the way through and not really stop at a certain stage and leave it for someone else.

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Months after achieving unicorn status, Orca steers into the fast lane with an RMAT designation for cell therapy candidate - Endpoints News

EdiGene Gets $67 Million Infusion to Bring Gene Editing to the Clinic – BioSpace

EdiGene raked in approximately $67 million in a series B financing round to further their genome-editing pipeline and expand the team. The Beijing-based biotech is currently leading the gene editing wave in China with four platforms steadily advancing.

Launched in 2015, EdiGenes pipeline was created around CRISPR gene editing technology. Right now, its fastest progressing projects are ET-01 for severe -thalassemia, a hereditary blood disease, and U Car-T ET-02 for cancer. CEO Dong Wei said thisround will help them transform their pipeline into clinical stage, drawing them closer to their goal of bringing innovative and high-quality gene-editing therapies to patients in need.

Their ET-01 therapy uses gene-editing technology to edit BCL11A erythroid enhancer in hematopoietic stem cells. The aim is to increase fetal hemoglobin levels in red blood cells for severe -thalassemia patients. These patients have few options and are desperate for better treatments.

For their second lead candidate, ET-02, EdiGene is leveraging their partner Immunochinas proprietary CAR-T to create a therapy that can edit immuno-rejection molecules in T cells from healthy donors to treat cancer patients.

CEO Dong Wei said of their partnerships potential, We believe that allogenic T-cell therapeutics has tremendous potential, by offering innovative T-cell therapies off the shelf with more effective quality control and lower cost.

EdiGene also has some in vivo therapies in research phase that use an RNA base editing approach using LEAPER technology. Their front-runner aims to treat Hurler Syndrome, the most severe form of mucopolysaccharidosis, a rare lysosomal storage disease resulting in a wide variety of symptoms caused by damage to several organ systems. They are also working on targeted therapeutics focused on solid tumor treatment.

The biotech has raised approximately $100 million in the last two years. This latest round of financing was led by 3H Health investment, with participation from new investors: Sequoia Capital China, Alwin Capital and Kunlun Capital. Previous partners IDG Capital, Lilly Asia Venture, Huagai Capital and Green Pine Capital Partners also joined in.

We are very pleased to have the support and partnership from our investors, which propels the company to an exciting new stage, said Wensheng Wei, Scientific Founder of EdiGene. Together with the investors, we look forward to translating cutting-edge gene editing technologies into innovative therapies, bringing hope and health to patients and their families.

EdiGene was recognized last year by CYZone, a leading innovation service platform, as one of their 2019 Top 50 Healthcare Innovation Enterprises in China.

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EdiGene Gets $67 Million Infusion to Bring Gene Editing to the Clinic - BioSpace