Thursday, May 7, 2020, 8:30 a.m. EDT

NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- BrainStorm-Cell Therapeutics Inc.(NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today, that the Company will hold a conference call to update shareholders on financial results for the first quarter endedMarch 31, 2020, and provide a corporate update, at 8:30 a.m, Eastern Daylight Time, onThursday, May 7, 2020.

BrainStorms CEO,Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will beRalph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PhD, MBA, Executive Vice President and Chief Operating Officer andPreetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to:q@brainstorm-cell.com. Questions should be submitted by5:00 p.m. EDT, Tuesday, May 5, 2020.

Teleconference Details BRAINSTORM CELL THERAPEUTICS 1Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

ABOUT NUROWNNurOwn (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

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 NurOwnCellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from theU.S. Food and Drug Administration(U.S.FDA) and theEuropean Medicines Agency(EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in theU.S., supported by a grant from theCalifornia Institute for Regenerative Medicine(CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S.FDAapproval of autologous MSC-NTF cells in ALS. BrainStorm received U.S.FDAclearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) inDecember 2018and has been enrolling clinical trial participants sinceMarch 2019. For more information, visit the company'swebsite.

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.

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BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update - Yahoo Finance

Updated: May 25, 2018:

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Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19 - JD Supra

Cryopreservation has become an indispensable step in the daily routine of scientific research as well as in a number of medical applications, ranging from assisted reproduction and transplantations to cell-based therapies and biomarker identification. It is hardly possible to picture todays scientific and medical advancements without this technique.The successful development and implementation of all the therapeutic and scientific discoveries involving cryopreservation relies on the correct and safe translation of the method from the laboratory to the clinical and manufacturing scale.

With the need to correctly use this technique, more research is focusing on optimizing cryopreservation methods and investigating what the long-term effects and consequences are on the physiology of the cryopreserved material.

An important part of cell therapy research is focused on adult stem cells (ASCs). ASCs can be derived from different sources such as peripheral blood, bone marrow or adipose tissue and display strong promises because of their capacity to differentiate into any cell type of the human body.In recent work3, the team of Michael Pepper at the Institute for Cellular and Molecular Medicine in Pretoria, South Africa, explored the effects of cryopreservation on the differentiation ability of adipose tissue-derived stem cells (ADSCs). After analyzing gene expression of key adipogenic genes and the degree of differentiating cells, characterized with high levels of CD36 and intracellular lipid droplets, the scientists reported that slow freeze cryopreservation of cells shortly after their isolation causes no alterations on their ability to differentiate. Pepper is convinced of the necessity to perform such analysis when cryopreserving important cell pools: It is critical to do a post-thaw analysis of cell function to determine how the cryopreservation may have affected the cells.His team is analyzing the effects of cryopreservation on other cell types largely used in cell-based therapies such as hematological stem cells and peripheral blood mononuclear cells (PBMCs). Although they didnt observe major alterations in terms of immunophenotyping or the post-thaw proliferation of the cells, Pepper expresses his concern that more subtle characteristics might be affected.

Correct cryopreservation of cells intended for therapeutic use is crucial. This is very important particularly as cells may persist for a long time in the recipient. This area of cell therapy research definitely requires more attention, Pepper says. Moreover, his words reflect on the need to evaluate not only the direct post-thaw recovery, but to look deeper into the late-onset effects cryopreservation might have and ensure that transplanted cells have preserved their therapeutic properties.

In contrast to slow freezing, vitrification relies on the fast freezing of the material by putting it in high concentration of cryoprotectant and in contact with liquid nitrogen. This method allows the direct transition of water from liquid to solid state without crystal formation. The highly concentrated cryoprotectant prevents ice formation and therefore there is no need for slow cooling.

Although vitrification has a great potential, there are a couple of parameters that are a point of concern. The quick and drastic freeze is possible thanks to the high concentration of cryoprotectant, but the latter is also associated with higher toxicity. In some cases, an additional limitation is the direct contact of the sample with liquid nitrogen which is a predisposition for viral or bacterial contamination.The team of Christiani Amorim at the Institute for Experimental and Clinical Research in Louvain, Belgium, is approaching the challenges of vitrification in the context of ovarian auto-transplantation. Ovarian auto-transplantation consists of preserving a piece of ovarian tissue with active follicles from the pre-therapeutic ovary of a cancer patient, as chemotherapy often has damaging effects on the reproductive organs. This tissue sample will be conserved and auto-transplanted onto the patients ovary when she has recovered and wishes to become pregnant.In their recent research4, the authors used stepped vitrification, in which the concentration of the cryoprotectant is gradually increased while simultaneously temperature decreases. This avoids ice crystal formation and also prevents cryoprotectant toxicity.Although stepped vitrification has previously given good results in bovine ovarian tissue5, this was not the case for human ovarian tissue. The scientists didnt detect normal follicles following thawing and linked this to high cryoprotectant toxicity. Indeed, they observed all signs of dimethyl sulfoxide (DMSO)-related cell membrane damage: significant organelle damage, cell membrane disintegration and apoptosis. These observations imply on the variability of outcomes that the method could give when applied to the same type of tissue but from a different organism.Amorim is positive about the future of their method and recognizes the need for further research on the topic: I can see a great potential in the stepped vitrification approach, but I also believe that there is a lot we still need to learn before thinking about using it as method of choice for human ovarian tissue cryopreservation. The high cryoprotectant concentration that should be applied in this approach is my first concern. () Our study clearly showed that 50% DMSO is too high, so we need to try lower concentrations or combine it with other cryoprotectants.

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Freezing Life: The Current Trends in Cryopreservation - Technology Networks

What is bone marrow cancer? Types, symptoms and treatment methods you must know  |  Photo Credit: Getty Images

New Delhi: Cancer is becoming a relatively very common disease, among people all around the world. It is a condition where abnormal cells divide uncontrollably in the body and destroy healthy body tissues as well. Cancer usually requires extensive treatment, and can also be life-threatening. Cancer accounted for 9.6 million deaths in 2018, according to WHO. Various popular personalities like Indian actors Irrfan Khan and Rishi Kapoor recently lost their lives to different types of cancer.

Rishi Kapoor was suffering from a bone marrow cancer, and breathed his last on Thursday morning, 30th of April. Here is what you need to know about bone marrow cancer, the cancer veteran actor was suffering from.

The bone marrow is a spongy tissue inside some of our bones. In humans, thesebones include the hips, thighs, etc. The bone marrow is the tissue where stem cells can develop into red blood cells, white blood cells, and platelets, all of which perform specific functions in the body.

Bone marrow cancer is a rare type of cancer. Bone marrow cancer happens when cells in the marrow start growing abnormally. It is a type of blood cancer and not bone cancer. Bone marrow cancer is the type that originates in the marrow and not the type that spreads to the bone or the marrow, after originating in some other part of the body.

Bone marrow cancer can be of various types, depending on the type of cells it affects -

Symptoms of bone marrow cancer vary, according to the type of cells that cancer affects. These include -

Multiple Myeloma Symptoms

Leukaemia symptoms

Lymphoma symptoms

Bone Marrow cancer can be treated by a medical professional. Chances of survival of the patient depend on the stage of cancer, how early the diagnosis is made, and other factors. Treatment methods include -

Disclaimer: Tips and suggestions mentioned in the article are for general information purposes only and should not be construed as professional medical advice. Always consult your doctor or a professional healthcare provider if you have any specific questions about any medical matter.

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What is bone marrow cancer? Leukaemia and other types, symptoms and treatment methods you must know - Times Now

Transforming old human cells into a youthful and vigorous state is what Regenerative Medicine is all about. Regenerative Therapy is a same-day nonsurgical procedure that involves working on cells and tissues either by replacing, engineering or growing them to establish normalcy. Contrary to surgeries, Regenerative Medicine gets to the root cause of the problem where stem cells communicate with the injured cells to initiate the healing process.

Stimulating the bodys mechanism to repair or heal tissues, regenerative therapy coaxes old human cells to express a panel of proteins involved in embryonic development. As cartilages, tendons, and nerves have limited healing capacity when compared to other parts of the body, regenerative therapies especially target these areas to treat common injuries, orthopedic problems or degenerative joint conditions.

Benefits of Regenerative Medicine

Regenerative medicines nullify the problem of reactions or infections. As it is a non-surgical procedure, it eliminates the pain and complications that occur otherwise. Enhancing healing and recovery, regenerative therapy is quick, long-lasting and mostly preferred by sportspersons. Biologic Products like PRP (platelet-rich plasma) and BMC (bone marrow concentrate) are actively developed for orthopedic procedures, enhancing usage potential and refinement.

PRP(Platelet Rich Plasma)

Focussed on patients platelets and blood cells, PRP releases concentrated proteins following implantation. The released proteins coordinate injured cells and stimulate healing.

BMC (Bone Marrow Concentrate)

Similar to PRP, BMC consists of several stem cells that have the potential to replace themselves as the original cells or can be used to release proteins and communicate with the injured cells to promote healing and repair.

Being an Ivy-trained physician and the founding CEO of Greyledge Technologies, Dr. Karlis medical practice integrates injection-based Regenerative Medicine and Cell Therapy techniques into a traditional non-operative orthopedic and sports medicine approach. Dr. David Karli develops biologic products in the regenerative medicine space. Earlier, degenerative joint problems were treated by blocking or inhibiting the bodys response to injury. Modernizing the traditional approach, Dr. Karli, at Greyledge Technologies prepares biologic products from a patients tissue and puts it back into the same patient. The human blood or bone marrow is processed as implantable materials.

During the biologic processing, he further collaborates with other medical faculty to develop and apply these products onto the injured tissues and stimulate healing. Dr. Karlis passion for regenerative medicine and the evolution of non-surgical procedures for various health problems helped him to develop Platelet Rich Plasma (PRP) and BMC(Bone Marrow Concentrate). The two stem cell injection therapy procedures cure acute and chronic musculoskeletal injuries.

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Familiarizing non-surgical Orthopaedic Treatments with Dr. David Karli - The American Reporter

Home Topics Lung Infection

Mesoblast announced data from a phase 2/3 trial evaluating remestemcel-L, an allogeneic mesenchymal stem cell product candidate, in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).

Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The randomized, placebo-controlled trial is being conducted at Mount Sinai hospital in New York City. Patients were treated with a variety of experimental agents prior to receiving remestemcel-L. Findings from the study showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of patients (n=9/12) were able to successfully come off ventilator support at a median of 10 days. There have been 7 patients discharged from the hospital as of now.

Mesoblast Chief Executive Dr. Silviu Itescu stated: The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

Additionally, the Food and Drug Administration recently accepted for Priority Review the Biologics License Application of remestemcel-L for the treatment of steroid-refractory acute graft vs host disease. The Company expects to launch remestemcel-L in 2020 if approved.

For more information mesoblast.com.

This article originally appeared on MPR

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Remestemcel-L Looks Promising for COVID-19 With Moderate to Severe ARDS - Pulmonology Advisor

Thefirst-in-human, universal chimeric receptor antigen (CAR) T-cell (CAR-T)therapy GC027 was tolerable and resulted in antileukemic responses amongpatients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL),according to results from a phase 1 trial presented at the American Associationfor Cancer Research (AACR) Virtual Annual Meeting I 2020.1

The universal CAR T cells target CD7, which, according to Xinxin Wang, PhD, of Gracell Biotechnologies Co, Ltd, in China, and lead author and presenter of the study, is a good target for T-ALL because it is expressed by more than 95% of T-ALL patients.

GC027 isallogeneic, which may prevent the development of graft-versus-host disease. Theproduct is introduced using lentivirus for rapid elimination of T-ALL cells. Preclinicalstudies showed efficacy in a T-ALL xenograft model, and this prospective studyevaluated the safety and efficacy in humans.

Thesingle-arm, open-label study treated 5 adult patients with relapsed/refractoryCD7-positive T-ALL with a single infusion of 1 of 3 different dose levels ofG027: 0.6 x 107/kg, 3 x 107/kg, and 1.5 x 107/kg.Lymphodepletion therapy was administered prior to the G027 infusion. Theprimary endpoint was safety and the secondary endpoints included objectiveresponse rate (ORR) within 3 months after G027 infusion.

Patients with extramedullary or central nervous system disease were excluded. At baseline, the median age was 24 (range, 19-38). Patients were heavily pretreated, with 5 median number of prior therapies (range, 1-9). Two patients had high-risk disease and the median bone marrow tumor burden was a median of 38.2% of blasts. None of the patients had undergone a prior allogeneic hematopoietic stem cell transplant.

Allpatients developed cytokine release syndrome (CRS), 4 of which were grade 3 and1 was grade 4. All cases were manageable and resolved with treatment andsupportive care. None of the patients developed neurotoxicity.

The completeremission (CR)/CR with incomplete hematologic recovery was 100%. By day 28, 4patients achieved a CR with negative for minimal residual disease (MRD) and 3of these patients remained MRD negative up to day 161. One patient achieved CRbut was MRD positive, and relapsed by day 29.

Peak CART-cell expansion in peripheral blood occurred between week 1 and 2.

As the first-in-human, universal CAR T-cell therapy for adult relapsed/refractory T-ALL, Dr Wang said, GC027 has demonstrated superior clinical efficacy and induced deep response in patients with acceptable safety profile. She added that trial enrollment is ongoing.

Reference

Wang X, Li S, Gao L, et al. Clinical safety and efficacy study of TruUCAR GC027: The first-in-human, universal CAR-T therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). Presented at: American Association for Cancer Research (AACR) Virtual Annual Meeting I; April 27-28, 2020. Abstract CT052.

This article originally appeared on Cancer Therapy Advisor

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First-in-Human Universal CAR-T Therapy Found Active in Relapsed/Refractory T-ALL - Hematology Advisor

BACKGROUND:

Osteoporosisis a metabolic bone disease characterized by low bone density resulting in increased fracture susceptibility. This research was constructed to uncover the potential therapeutic application of osteoblasts transplantation, generated upon culturing male rat bone marrow-derived mesenchymal stem cells (BM-MSCs) in osteogenic medium (OM), OM containing gold (Au-NPs) or gold/hydroxyapatite (Au/HA-NPs) nanoparticles, in ovariectomized rats to counteractosteoporosis.

Forty rats were randomized into: (1) negative control, (2) osteoporotic rats, whereas groups (3), (4) and (5) constituted osteoporotic rats treated with osteoblasts yielded from culturing BM-MSCs in OM, OM plus Au-NPs or Au/HA-NPs, respectively. After 3months, osterix (OSX), bone alkaline phosphatase (BALP), sclerostin (SOST) and bone sialoprotein (BSP) serum levels were assessed. In addition, gene expression levels of cathepsin K, receptor activator of nuclear factor-b ligand (RANKL), osteoprotegerin (OPG) and RANKL/OPG ratio were evaluated using real-time PCR. Moreover, histological investigation of femur bone tissues in different groups was performed. The homing of implanted osteoblasts to the osteoporotic femur bone of rats was documented by Sex determining region Y gene detection in bone tissue.

Our results indicated that osteoblasts infusion significantly blunted serum BALP, BSP and SOST levels, while significantly elevated OSX level. Also, they brought about significant down-regulation in gene expression levels of cathepsin K, RANKL and RANKL/OPG ratio versus untreated osteoporotic rats. Additionally, osteoblasts nidation could restore bone histoarchitecture.

These findings offer scientific evidence that transplanting osteoblasts in osteoporotic rats regains the homeostasis of the bone remodeling cycle, thus providing a promising treatment strategy for primaryosteoporosis.

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Osteoblast-Based Therapy-A New Approach for Bone Repair in Osteoporosis: Pre-Clinical Setting - DocWire News

This Placental Stem Cells (PSCS) industry report provides comprehensive analysis as follows Market segments and sub-segments, Market size, Market trends and flow, Major Manufacturers Production and Sales Market Comparison Analysis, Drivers and Opportunities, Competitive scene, Product Specification and Major Types Analysis, Supply and demand, Regional Production Market Analysis, Regional Market Performance and Market Share. The Placental Stem Cells (PSCS) market research report covers effectiveness and summary of the marketing research. These results can be employed to make improvements in the business. The report helps to save a large amount of time and money that may get spend on marketing.

Get ExclusiveSample Copy of This Report Herehttps://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-placental-stem-cells-pscs-market

Placentalstem cells(PSCS) market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to growing at a CAGR of 10.25% in the above-mentioned forecast period. Increasing awareness regarding the benefits associates with the preservation of placental derived stem cells will boost the growth of the market.

The major players covered in theplacental stem cells (PSCS) marketreport areCBR Systems, Inc, Cordlife India, Cryo-Cell International, Inc., ESPERITE N.V., LifeCell International Pvt. Ltd., StemCyte India Therapeutics Pvt. Ltd, PerkinElmer Inc, Global Cord Blood Corporation., Smart Cells International Ltd., Vita 34, among other domestic and global players. Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately.DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Market Analysis and Insights of Global Placental Stem Cells (PSCS) Market

Adoption of advances and novel technologies that will lead to the storage and preservation of stem cells, technological advancement in the field of biotechnology, introduction of hematopoietic stem cell transplantation system and growing number of diseases which will helps in accelerating the growth of the placental stem cells (PSCS) market in the forecast period of 2020-2027. Surging number of applications from emerging economies along with rising awareness among the people will further boost many opportunities that will led to the growth of the placental stem cells (PSCS) market in the above mentioned forecast period.

Increasing operation costs along with stringent regulatory framework will likely to hamper the growth of the placental stem cells (PSCS) market in the above mentioned forecast period. Social and ethical issues will be the biggest challenge in the growth of the market.

Thisplacental stem cells(PSCS) market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on placental stem cells (PSCS) market contactData Bridge Market Researchfor anAnalyst Brief, our team will help you take an informed market decision to achieve market growth.

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Global Placental Stem Cells (PSCS) Market Scope and Market Size

Placental stemcells(PSCS) market is segmented on the basis of service type and application. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Placental Stem Cells (PSCS) Market Country Level Analysis

Placental stemcells(PSCS) market is analysed and market size insights and trends are provided by country, service type and application as referenced above.

The countries covered in the placental stem cells (PSCS) market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the bone marrow-derived stem cells (BMSCS) market due to the increasing stem cell procedure along with preferences of private stem cell banking over public and surging network of stem cell banking services.

The country section of the placental stem cells (PSCS) market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Placental stem cells (PSCS) market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for placental stem cells (PSCS) market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the placental stem cells (PSCS) market. The data is available for historic period 2010 to 2018.

Competitive Landscape and Placental Stem Cells (PSCS) Market Share Analysis

Placental stem cells (PSCS) market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to placental stem cells (PSCS) market.

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Placental Stem Cells (PSCS) Market is Prospering With Healthy CAGR in 2020. Leading Players are Cryo-Cell International, Inc., ESPERITE NV, LifeCell...

VANCOUVER, Washington, April 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administration's (FDA) emergency Investigational New Drug (eIND) program:

Eleven (11) Patients in NY hospital: All treated patients were in Intensive Care Units (ICU) because of acute respiratory failure, eight of whom were intubated (placed on mechanical ventilation). One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, we believe we were able to save the lives of four patients. All patient blood samples were evaluated and important powerful results from the effect of leronlimab were demonstrated in almost all of these patients. This data has been submitted to a prestigious journal and we expect the publication on Friday, May 1.

Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients.

Three (3) patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of leronlimab treatment. Of these 3 patients, 2 were extubated (taken off ventilator) and 1 patient remains on a ventilator but improving.

One (1) patient in another NY hospital: Patient was taken off oxygen and discharged from hospital after leronlimab treatment.

One (1) patient in Northern California hospital: Patient is now weaning from ventilator and transferred to rehabilitation hospital.

Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, "We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days."

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, "We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results."

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Company's cash position, (ii)the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv)the Company's ability to enter into partnership or licensing arrangements with third parties, (v)the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Company's ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Company's clinical trials, (viii)the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries -...

BOCA RATON, Fla., April 29, 2020 /PRNewswire/ -- While most of the country has been on lockdown due to the coronavirus crisis, Gift of Life Marrow Registry donor Drake Jackson, traveled 1,000 miles to save the life of a stranger by donating his stem cells to a cancer patient in need of an urgent transplant. The 23-year-old was inspired by his hero and MLB professional baseball player Matt Szczur, who, in 2009 donated bone marrow to a young leukemia patient he had never met.

Jackson was an undergraduate at Illinois State University when he heard of Szczur's heroic act. "I'm a Chicago Cubs fan and when I found out that Matt [who played for the team at the time] had made this incredible donation to save a life, I felt that joining the registry was an easy thing to do to possibly help someone," said Jackson.

So, in November 2016, Jackson searched the internet and found Gift of Life Marrow Registry. He ordered a swab kit online and three years later he was called as a match for a patient battling leukemia.

Jackson was at work when Gift of Life's call came. Undaunted by the growing pandemic, he traveled to Florida in March from Illinois to the Dr. Miriam and Sheldon G. Adelson Gift of Life-Be The Match Collection Center to donate his lifesaving stem cells. "I encourage anyone to join the registry. It's super easy and everyone at Gift of Life is amazing, said Jackson."

After his procedure, Jackson connected with Szczur on social media and the two bonded over their experience as donors. So, when Jackson decided to shift his weddingoriginally planned for May in Key Westonline on April 22, Szczur's participation via video came as a special gift.

"I was honored to have been able to give a child a chance to live out her life when I donated bone marrow all those years ago," said Szczur. "To learn about the ripple effect of not only helping to save a life, but also inspiring Drake to do the same, is truly amazing. In these times of great difficulty, his story brings hope and a reminder that it takes just one person to make a difference."

To join the Gift of Life registry from home, potential donors can request a registration kit at giftoflife.org/register.

About Gift of Life Marrow RegistryGift of Life Marrow Registry is a 501(c)(3) nonprofit organization headquartered in Boca Raton, Fla. The organization, established in 1991, is dedicated to saving lives by facilitating bone marrow and blood stem cell transplants for patients with leukemia, lymphoma, and other blood-related diseases. To learn more about Gift of Life Marrow Registry, visit http://www.giftoflife.org.

Media contact: Edwige Buteau, Gift of Life Marrow RegistryOffice: +1 (516) 982-2921; Cell: +1 (917) 655-3843; [emailprotected]

SOURCE Gift of Life Marrow Registry

http://www.giftoflife.org

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MLB Player Inspired Baseball Fan To Save Life Of Leukemia Patient During Pandemic - PRNewswire

Doctors are hoping stem cell therapy could be a weapon in the fight against coronavirus. On Friday, regenerative medicine company Mesoblast announced a 300-person trial to determine whether stem cell treatments will work in COVID-19 patients suffering from severe lung inflammation.

One hospital in New York tried it as an experiment with 12 patients, 10 of whom were able to come off of ventilators.

"What we saw in the very first patient was that within four hours of getting the cells, a lot of her parameters started to get better," Dr. Karen Osman, who led the team at Mount Sinai, told CBS News' Adriana Diaz.

The doctor said she was encouraged by the results, though she was hesitant to link the stem cell procedure to her patients' recovery.

"We don't know" if the 10 people removed from ventilators would not have gotten had they not gotten the stem cells, she said. "And we would never dare to claim that it was related to the cells."

She explained that only a "randomized controlled trial" would be the only way "to make a true comparison."

Luis Naranjo, a 60-year-old COVID-19 survivor, was one of Mount Sinai's stem cell trial success stories. He told Diaz in Spanish that he was feeling "much better."

Naranjo's daughter, Paola, brought him to the emergency room, fearful she would not see her father again. Like so many families struck by the coronavirus, she was not allowed inside with him.

"I forgot to tell him that I love him," she said. "All I said was go inside, I hope you feel better."

During his hospital stay, Naranjo was unconscious and on a ventilator for 14 days.

Doctors proposed giving him stem cells from bone marrow in hopes it would suppress the severe lung inflammation caused by the virus.

Now, Naranjo credits the doctors who treated him for his survival. Though income from his family's jewelry business has been cut off and they found themselves falling behind on rent, Naranjo said he is focused primarily on his recovery and regaining the 25 pounds he lost at the hospital.

Although stem cell treatment, usually reserved for other diseases like rheumatoid arthritis, might end up being another step toward helping coronavirus patients recover, Dr. Osman was quick to say it would not be a "miracle treatment."

"The miracle treatment will be a vaccine," she said.

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Doctors experiment with unproven stem cell therapy on COVID-19 patients - CBS News

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Doctors treating severe COVID-19 instances in New York attempted stem cell treatment on 12 patients, 10 of whom came off ventilators after receiving treatment.

It is uncertain whether the publication coronavirus disease could be treated with stem cells, but scientists in Mesoblast are going to conduct a clinical trial on 300 serious patients to find more replies.

Anecdotal evidence suggests that stem cells can be helpful, however, the science behind it has to be clarified. The book coronavirus might not have a remedy right now, but it is still worth noting the huge research effort which goes into discovering treatments that could restrict COVID-19 complications and prevent death.

Doctors have observed the positive effects of a garden range of drugs that are supposed to treat other disorders, and some of these medicines are contained in enormous trials across the world. Scientists are also working on over 70 vaccine applicants for COVID-19, using some of them showing promising results. In addition to that, theres plasma from predators that is rich in antibodies which may help individuals with weaker immune systems.

And doctors think they have found another promising remedy for COVID-19: Stem cells. You frequently hear about stem cells and these reports are often miraculous. Stem cells are human cells which have thesuperpower to change into just about any cell of their human body and they can be used to treat some health problems. Stem cells can regenerate lung tissue, fight inflammation, and help acute COVID-19 patients breathe on their own back.

Doctors at Mount Sinai treated 12 patients with stem cell treatment, and 10 of these came off their ventilators soon after, CBSNews reports. The doctors themselves have no idea what helped the patients improve, and cant definitively say that its the stem cells that stored their patients.

What we saw in the very first patient was that within four hours of getting the cells, a lot of her parameters started to get better, Dr. Karen Osman advised CBS. The doctor made it clear they cant claim the stem cell treatments are what saved the sufferers. We dont know, she said. And wed never dare to assert that it had been associated with the cells.

The doctor explained that just a randomized controlled trial would have the ability to inform them whether the stem cells can assist with the recovery of COVID-19 patients. Thankfully, one particular study is going to get underway. Mesoblast will trial stem cell treatments on 300 patients suffering from severe lung inflammation. Osman and her staff think that stem cells extracted from bone marrow could suppress the inflammation in COVID-19 patients, and that is why they tried the treatment. Naranjo has recovered following stem cell treatment, and hes at home focusing on regaining his strength.

The miracle treatment is going to be a vaccine. While we await any Type of effective COVID-19 treatment, heres a simple explainer for stem cells:

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New York Is Going To Conduct Stem Cell Treatment For COVID-19 Patients - World Top Trend

In an unfortunate development, actor Rishi Kapoor lost his long battle with Leukemia. As we all know, the actor had travelled to the US for his treatment earlier and came back looking younger and healed. But he has had his share of health issues ever since. The family had been referring to the treatment as marrow and today the family confirmed that the actor was struggling with leukemia. Let us first understand what leukemia is - Leukemia is cancer of the body's blood-forming tissues, which includes the bone marrow as well as the lymphatic system. There are several types of leukemia, and some even affect the children, however, mostly leukemia occurs in adults. According to Cancer.org, most often, AML develops from cells that would turn into white blood cells (other than lymphocytes), but sometimes AML develops in other types of blood-forming cells. . To understand the course of treatment that the actor may have undergone, we spoke exclusively to subject matter expert Dr Rahul Bhargava, Director, Haematology, Haemato - Oncology and Bone Marrow Transplant, Fortis Memorial Research Institute, Gurugram. The doctor says the way it appears, the star must have suffered from Acute myeloid leukemia (AML) which is a cancer that starts in the bone marrow, which is the soft inner part of certain bones, where the body makes new blood cells. This often quickly moves into the blood, as well. Talking about the treatment for this particular illness, Dr Bhargava said, There is a possibility that he underwent a MUD (Match unrelated donor) transplant with reduced intensity conditioning (RIC), which basically means that he was given a lower intensity treatment, considering his age. How does MUD work?In MUD, stem cells from outside are injected in the body, and mature stem cells are targeted and removed. A person has to be in the hospital for close to 21-25 days for this procedure and then we wait and see how the body responds to the treatment. The doctor adds that clearly the treatment couldnt control his disease and he succumbed to it.

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Rishi Kapoor succumbs to Leukemia: Here is all we know about the condition and treatment - Times of India

Thefirst-in-human, universal chimeric receptor antigen (CAR) T-cell (CAR-T)therapy GC027 was tolerable and resulted in antileukemic responses amongpatients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL),according to results from a phase 1 trial presented at the American Associationfor Cancer Research (AACR) Virtual Annual Meeting I 2020.1

Theuniversal CAR T cells target CD7, which, according to Xinxin Wang, PhD, ofGracell Biotechnologies Co, Ltd, in China, and lead author and presenter of thestudy, is a good target for T-ALL because it is expressed by more than 95% ofT-ALL patients.

GC027 isallogeneic, which may prevent the development of graft-versus-host disease. Theproduct is introduced using lentivirus for rapid elimination of T-ALL cells. Preclinicalstudies showed efficacy in a T-ALL xenograft model, and this prospective studyevaluated the safety and efficacy in humans.

Thesingle-arm, open-label study treated 5 adult patients with relapsed/refractoryCD7-positive T-ALL with a single infusion of 1 of 3 different dose levels ofG027: 0.6 x 107/kg, 3 x 107/kg, and 1.5 x 107/kg.Lymphodepletion therapy was administered prior to the G027 infusion. Theprimary endpoint was safety and the secondary endpoints included objectiveresponse rate (ORR) within 3 months after G027 infusion.

Patientswith extramedullary or central nervous system disease were excluded. Atbaseline, the median age was 24 (range, 19-38). Patients were heavilypretreated, with 5 median number of prior therapies (range, 1-9). Two patientshad high-risk disease and the median bone marrow tumor burden was a median of38.2% of blasts. None of the patients had undergone a prior allogeneic hematopoieticstem cell transplant.

Allpatients developed cytokine release syndrome (CRS), 4 of which were grade 3 and1 was grade 4. All cases were manageable and resolved with treatment andsupportive care. None of the patients developed neurotoxicity.

The completeremission (CR)/CR with incomplete hematologic recovery was 100%. By day 28, 4patients achieved a CR with negative for minimal residual disease (MRD) and 3of these patients remained MRD negative up to day 161. One patient achieved CRbut was MRD positive, and relapsed by day 29.

Peak CART-cell expansion in peripheral blood occurred between week 1 and 2.

As the first-in-human, universal CAR T-cell therapy for adult relapsed/refractory T-ALL, Dr Wang said, GC027 has demonstrated superior clinical efficacy and induced deep response in patients with acceptable safety profile. She added that trial enrollment is ongoing.

Read more of Cancer Therapy Advisors coverage of AACR 2020 meeting by visiting the conference page.

Reference

Wang X, Li S, Gao L, et al. Clinical safety and efficacy study of TruUCAR GC027: The first-in-human, universal CAR-T therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). Presented at: American Association for Cancer Research (AACR) Virtual Annual Meeting I; April 27-28, 2020. Abstract CT052.

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First-in-Human Universal CAR-T Therapy Found Active in Relapsed/Refractory T-ALL - Cancer Therapy Advisor

A novel,bispecific CD19/CD22 chimeric antigen receptor T-cell (CAR-T) therapy wastolerable and resulted in responses among patients with acute lymphoblasticleukemia (ALL), according to results from a phase 1 trial presented at the AmericanAssociation for Cancer Research (AACR) Virtual Annual Meeting I 2020.

Thenovel CAR-T therapy was developed with the hypothesis that dual antigen-targetingstrategies may prevent antigen negative escape, Haneen Shalabi, DO, of theNational Cancer Institute and lead author and presenter of the study, said.

Thephase 1, dose-escalation study treated 13 young patients with ALL with theCD19/CD22 CAR-T therapy at 3 different dose levels, including 3 x 105,1 x 106, and 3 x 106. The bispecific construct containedFMC63 (CD19 scFv) linked with m971 (CD22 scFv) and a 4-1 BB costimulatorydomain.

Patientsunderwent lymphodepletion with fludarabine plus cyclophosphamide prior to theirCAR-T infusion. The primary endpoints were safety and toxicity, and thesecondary endpoints were efficacy, chimeric antigen receptor (CAR) expansion,and CAR persistence.

Atbaseline, the median age was 19.6 (range, 5.4-28.5). Patients had receivedprevious treatments, including hematopoietic stem cell transplant (54%),CD19-targeted therapy (69%), prior CD19 CAR T cell therapy (38.4%),blinatumomab (61.5%), CD22-targeted therapy (38.4%), inotuzumab (30.7%), andCD22 CAR-T therapy (15.4%). Extramedullary disease was present in 46.2% ofpatients.

CAR Tcells were well tolerated and toxicities were reversible in all patients, DrShalabi said.

Cytokinerelease syndrome (CRS) developed in 46% of patients, 15.4% of which was grade 3or higher. Both patients who developed grade 3 or higher CRS had received the 1x 106 dose level of the CD19/CD22 CAR-T product and both requiredtreatment with tocilizumab. One patient developed neurotoxicity, and hadreceived the 3 x 106 dose level.

Of the12 patients evaluable for efficacy, a complete response (CR) was achieved by42% (5) of patients, including all patients who received the 1 x 106 or 3 x 106 dose levelsof the CD19/CD22 CAR-T therapy. There were 2 nonresponders.

Two patientswho received 1 x 106 CAR-T and all patients who received the 3 x 106dose level were negative for minimal residual disease (MRD), with the remainingCRs demonstrating bone marrow clearance. Four of the 5 patients who were MRDnegative were also naive to CAR-T therapy.

Of the 5patients who achieved a CR, 2 relapsed with CD19-positive/CD22-positive diseaseand 3 remained in remission at a median 7 months after CAR T cell infusion.

Severalpatients, however, who were MRD negative in the bone marrow did not achieve CRin their extramedullary disease. Dr Shalabi said that these discrepant resultsbetween marrow and extramedullary disease suggests potentially limited CAR-Ttrafficking to sites of extramedullary disease. She suggested that treatmentat higher dose levels may be needed to overcome this limitation.

CAR T-cellexpansion occurred in all patents who responded, with a median peak inperipheral blood of 7%. At day 28, there were 1.3% CAR T cells in the bonemarrow. The persistence of the CAR T cells in peripheral blood was a median of45.6 days, as measured by flow cytometry.

Dr Shalabi concluded that this early experience with bispecific CD19/CD22 CAR T cells demonstrates clinical activity with reversible CRS and limited neurotoxicity. She noted that future studies will explore a 1 x 107 dose level, intensification of lymphodepletion prior to CAR-T infusion, and consideration of the potential role of immune checkpoint inhibitors to augment CAR-T in extramedullary disease.

Read more of Cancer Therapy Advisors coverage of AACR 2020 meeting by visiting the conference page.

References

Shalabi H, Yates B, Shahani S, et al. Safety and efficacy of CD19/CD22 CAR T cells in children and young adults with relapsed/refractory ALL. Presented at: American Association for Cancer Research (AACR) Virtual Annual Meeting I 2020; April 27-28, 2020. Abstract CT051.

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Novel Bispecific CD19/CD22 CAR-T Therapy Deemed Tolerable in Relapsed/Refractory ALL - Cancer Therapy Advisor

NEW YORK, April 29, 2020 (GLOBE NEWSWIRE) -- BrainStorm-Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today, that the Company will hold a conference call to update shareholders on financial results for the first quarter ended March 31, 2020, and provide a corporate update, at 8:30 a.m, Eastern Daylight Time, on Thursday, May 7, 2020.

BrainStorms CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PhD, MBA, Executive Vice President and Chief Operating Officer and Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. EDT, Tuesday, May 5, 2020.

Teleconference Details BRAINSTORM CELL THERAPEUTICS 1Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

ABOUT NUROWNNurOwn (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

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 Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

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, 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 at http://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: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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BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate UpdateThursday, May 7, 2020, 8:30 am EDT - BioSpace

Stem Cell Therapy market describes in-depth assessments and professional studies of the current and future status of the market worldwide, including valuable facts and figures. Stem Cell Therapy markets enhance this growth trend by providing information on new opportunities and market drivers, trends and future technologies. This report defines scope, coverage, production and CAGR (%) according to type, share, revenue status and outlook, capacity, consumption, market drivers, production status and outlook and opportunities, exports, imports, emerging market / national growth rates. This report provides a 360-degree overview of the industrys competitive environment. The Stem Cell Therapy market report evaluates key regions (countries) with a large market share during the forecast period.

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Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 - Latest Herald

VANCOUVER, Washington, April 29, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Nader Pourhassan, Ph.D., President and Chief Executive Officer, and Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic services provider and an advisor to CytoDyn, will provide a comprehensive update on leronlimab for COVID-19. The Wall Street Reporter's event is scheduled for Friday, May 1, 2020 at 12:30 pm ET / 9:30 am PT.

Dr. Pourhassan will provide an update on patient enrollment in eIND, Phase 2 and Phase 2b/3 COVID-19 trials. Dr. Patterson will discuss his latest discovery of the mechanism of action of COVID-19 and the effect of leronlimab.

Interested participants are encouraged to login early prior to the start of the event, as the online event has a capacity of 3,000 participants and the Company's recent investment community conference call had over 3,600 participants. The livestream presentation will be archived for 30 days. For anyone unable to attend, a video will be posted on CytoDyn's website approximately 24 hours after the presentation. The conference sponsor provides corporate visibility services to CytoDyn for a fee.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Company's cash position, (ii)the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv)the Company's ability to enter into partnership or licensing arrangements with third parties, (v)the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Company's ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Company's clinical trials, (viii)the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn's Drs. Pourhassan and Patterson to Present Live at Wall Street Reporter's Event to Discuss Paper Recently Submitted for Publication and...

DURHAM, N.C., April 29, 2020 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced the Companys initiation of a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).

DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.1

Given the severity of the COVID-19 pandemic, we have evaluated many potential targets to address the clinical manifestations associated with severe COVID-19,said Joseph Lasky, M.D., Professor of Medicine, Pulmonary and Critical Care Section Chief, John W. Deming, M.D. Endowed Chair in Internal Medicine at Tulane University Medical School. Based on the literature, we believe DSTAT has the potential to reduce the excessive inflammation, immune cell infiltration and hypercoagulation associated with poor outcomes in patients with severe COVID-19 infection.

DSTAT is well-suited to unlock the anti-inflammatory properties of heparin as it may be dosed at much higher levels than any available form of heparin without triggering bleeding complications, said Mike Sherman, Chief Executive Officer of Chimerix. We had planned to evaluate DSTAT in several indications of high unmet need, including ALI from different causes. The pandemic intensified our focus on ALI associated with COVID-19. Our team has worked closely with critical care physicians treating COVID-19 patients and with the U.S. Food and Drug Administration (FDA) to develop a Phase 2/3 protocol to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in patients with severe COVID-19 infection.

Phase 2/3 Study Design

The study is a 1:1 randomized, double-blind, placebo-controlled, Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at high risk of respiratory failure. Eligible subjects will be those with confirmed COVID-19 who require hospitalization and supplemental oxygen therapy. The primary endpoint of the study is the proportion of subjects who survive and do not require mechanical ventilation through day 28. Additional endpoints include time to improvement as assessed by the National Institute of Allergy and Infectious Disease ordinal scale, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality, and changes in key biomarkers (e.g. interleukin-6 (IL-6), tumor necrosis factor- (TNF-), high mobility group box 1 (HMGB1), C-reactive protein and d-dimer).

The Phase 2 portion of the study will enroll 24 subjects to confirm the maximum safe dose and will then expand by an additional 50 patients (74 total) at the selected dose. A formal analysis of all endpoints, including supportive biomarkers will be performed at the conclusion of the phase 2 portion of the study. Contingent upon positive results, the Phase 3 portion of the study will enroll approximately 450 subjects.

Clinical Rationale for DSTAT in COVID-19 Patients with ALI

The clinical manifestations of COVID-19 range from mild, self-limited respiratory tract illness to severe alveolar damage and progressive respiratory failure, multiple organ failure, and death. Mortality in COVID-19 is associated with severe pulmonary disease and coagulation disorders such as disseminated intravascular coagulation (DIC).2,3

The mechanistic rationale supporting DSTATs potential in ALI patients with COVID-19 is two-fold:

In a recent Phase 2 Acute Myeloid Leukemia (AML) study DSTAT was well tolerated with adverse events similar across DSTAT and control groups. DSTAT is an investigational agent, not yet licensed or approved for use.

Conference Call and Webcast

Chimerix will host a conference call and live audio webcast today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 8263766.

A live audio webcast of the call will also be available on the Investors section of Chimerixs website, http://www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.

About Chimerix

Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. Its two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

Dociparstat sodium is a potential first-in-class glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity In vitro and in vivo animal model data support DSTATs potential to reduce the inflammation and cellular infiltration associated with acute lung injury and address coagulation disorders associated with COVID-19 pathology. Separately, DSTAT inhibits the activities of several key proteins implicated in the viability of AML blasts and leukemic stem cells in the bone marrow during chemotherapy (e.g., CXCL12, selectins, HMGB1, elastase). Randomized Phase 2 data suggest that DSTAT may also accelerate platelet recovery post-chemotherapy via inhibition of PF4, a negative regulator of platelet production that impairs platelet recovery following chemotherapy. BCV is an antiviral drug candidate in development as a medical countermeasure for smallpox. For further information, please visit the Chimerix website, http://www.chimerix.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the mechanism of action of DSTAT and its potential in ALI patients with COVID-19; Chimerixs ability to develop DSTAT, including the initiation of a Phase 2/3 clinical trial for DSTAT as a potential treatment for ALI associated with COVID-19; and Chimerixs ability to submit and/or obtain regulatory approvals for DSTAT. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that DSTAT may not achieve the endpoints of the Phase 2/3 clinical trial; risks that DSTAT may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that development activities related to DSTAT may not be completed on time or at all; Chimerixs reliance on a sole source third-party manufacturer for drug supply; risks that ongoing or future trials may not be successful or replicate previous trial results, or may not be predictive of real-world results or of results in subsequent trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for our drugs; risks that our drugs may be precluded from commercialization by the proprietary rights of third parties; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

CONTACT:Investor Relations:Michelle LaSpaluto919 972-7115ir@chimerix.com

Will OConnorStern Investor Relationswill@sternir.com212-362-1200

Media:David SchullRusso Partners858-717-2310david.schull@russopartnersllc.com

note: DSTAT may be referred to as 2-O,3-O desulfated heparin, ODSH or CX-01 in these references.

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Chimerix Announces Initiation of a Phase 2/3 Study of DSTAT in Acute Lung Injury for Patients with Severe COVID-19 - BioSpace