Category Archives: Somatic Stem Cells

Large-scale RNAi screening uncovers therapeutic targets in the parasite Schistosoma mansoni – Science Magazine

Schistosome biology illuminated

Schistosomiasis is caused by a parasitic flatworm about which little is known. Therefore, options to combat human disease caused by schistosome infection are limited. To aid in our quest to develop treatments, two studies undertook molecular investigations of the parasite Schistosoma mansoni. By generating a single-cell atlas, Wendt et al. identified the developmental trajectory of the flatworm, including the blood-feeding gut required for its survival in the host. From these data, they found a gene required for gut development that, when knocked out through RNA interference, confers reduced pathology in infected mice. Wang et al. performed a large-scale RNA interference survey of S. mansoni and identified an essential pair of protein kinases that can be targeted by approved pharmacological intervention (see the Perspective by Anderson and Duraisingh). These molecular investigations add to our understanding of the schistosome parasite and provide biological information that may help to combat this neglected tropical disease.

Science, this issue p. 1644, p. 1649; see also p. 1562

Schistosome parasites kill 250,000 people every year. Treatment of schistosomiasis relies on the drug praziquantel. Unfortunately, a scarcity of molecular tools has hindered the discovery of new drug targets. Here, we describe a large-scale RNA interference (RNAi) screen in adult Schistosoma mansoni that examined the function of 2216 genes. We identified 261 genes with phenotypes affecting neuromuscular function, tissue integrity, stem cell maintenance, and parasite survival. Leveraging these data, we prioritized compounds with activity against the parasites and uncovered a pair of protein kinases (TAO and STK25) that cooperate to maintain muscle-specific messenger RNA transcription. Loss of either of these kinases results in paralysis and worm death in a mammalian host. These studies may help expedite therapeutic development and invigorate studies of these neglected parasites.

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Large-scale RNAi screening uncovers therapeutic targets in the parasite Schistosoma mansoni – Science Magazine

Strategic Analysis to Understand the Competitive Outlook of Cell Therapy Manufacturing Market – The News Brok

Prophecy Market Insights Cell Therapy Manufacturing market research report provides a comprehensive, 360-degree analysis of the targeted market which helps stakeholders to identify the opportunities as well as challenges. The research report study offers keen competitive landscape analysis including key development trends, accurate quantitative and in-depth commentary insights, market dynamics, and key regional development status forecast 2020-2029. It incorporates market evolution study, involving the current scenario, growth rate, and capacity inflation prospects, based on Porters Five Forces and DROT analyses.

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An executive summary provides the markets definition, application, overview, classifications, product specifications, manufacturing processes; raw materials, and cost structures.

Market Dynamics offers drivers, restraints, challenges, trends, and opportunities of the Cell Therapy Manufacturing market

Segment Level Analysis in terms of types, product, geography, demography, etc. along with market size forecast

Regional and Country- level Analysis different geographical areas are studied deeply and an economical scenario has been offered to support new entrants, leading market players, and investors to regulate emerging economies. The top producers and consumers focus on production, product capacity, value, consumption, growth opportunity, and market share in these key regions, covering

The comprehensive list of Key Market Players along with their market overview, product protocol, key highlights, key financial issues, SWOT analysis, and business strategies. The report dedicatedly offers helpful solutions for players to increase their clients on a global scale and expand their favour significantly over the forecast period. The report also serves strategic decision-making solutions for the clients.

Competitive landscape Analysis provides mergers and acquisitions, collaborations along with new product launches, heat map analysis, and market presence and specificity analysis.

Segmentation Overview:

Cell Therapy ManufacturingMarket Key Companies:

harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

The Cell Therapy Manufacturing research study comprises 100+ market data Tables, Graphs & Figures, Pie Chat to understand detailed analysis of the market. The predictions estimated in the market report have been resulted in using proven research techniques, methodologies, and assumptions. This Cell Therapy Manufacturing market report states the market overview, historical data along with size, growth, share, demand, and revenue of the global industry.

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The study analyses the manufacturing and processing requirements, project funding, project cost, project economics, profit margins, predicted returns on investment, etc. This report is a must-read for investors, entrepreneurs, consultants, researchers, business strategists, and all those who have any kind of stake or are planning to foray into the Cell Therapy Manufacturing industry in any manner.

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Strategic Analysis to Understand the Competitive Outlook of Cell Therapy Manufacturing Market – The News Brok

Stem Cells Market Development Status, Emerging Technologies, Regional Trends and Comprehensive Research Study 2025 – The Daily Chronicle

Stem Cells Market Analysis According to Market Research, the Global Stem Cells Market was valued at USD 5.88 Billion in 2018 and is expected to witness a growth of 10.32% from 2019-2026 and reach USD 12.96 Billion by 2026.

What is Stem Cells Market? Stem cellscan be defined as unspecialized cells that develop into the specialized cells and make up different types of tissue in the human body. Since stem cells are unspecialized type of cells and are capable of renewing themselves through cell division. Stem cells can be Pluripotent as well as Multipotent. Pluripotent stem cells are stem cells usually found in embryos which give rise to all the cells found in the human body, while multipotent stem cells, which are found in adults or in babies umbilical cords, have a more restricted ability. Their development is limited to cells that form the organ system that they are originated from. When a stem cell undergoes division, each new cell possess a potential either to remain a stem cell or develop into another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

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Stem Cells Market Outlook Stem cell research is considered as one of the most intriguing areas of contemporary biology, but, as with many expanding fields of scientific inquiry, research on stem cells stimulates scientific queries as rapidly as it produces new discoveries. Until recently, scientists used to primarily work with two types of stem cells from animals and humans: embryonic stem cells and non-embryonic somatic or adult stem cells.

Since the advent of stem cells, one of the crucial benefits of stem cell research is the accessibility of cell lines and that they can be acquired ethically. The demands for pluripotent stem cells are increasing owing to the fact that it differentiates in various cell types in the human body. Pluripotent stem cells tend to have various applications in the medical treatment. Growing awareness regarding the stem cells and establishment of stem cell banks is expected to fuel the market growth rate.

The Final Report will cover the impact analysis of COVID-19 on this industry:

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Ethical issues related to pluripotent stem cells could hamper the growth of stems cells in the global market as research with these cells require disrupting an artificially-fertilized embryo at the 5-14 day stage. Another factor which is limiting the growth of stem cells market is unknown long-term consequences.

Global Stem Cells Market Segmentation TheGlobal Stem Cells Marketis classified on the basis of Product, Treatment Type, Therapeutic Application and Region. The gist of breaking down the market into various segments is to gather the information about various aspects of the market.

On the basis of Products, the market is bifurcated on the basis of Adult Stem Cells, Human Embryonic Cells, and Induced Pluripotent Stem Cell. Adult stem cells accounts for a major share in the global stem cells market. Even though embryonic stem cells have a wide range of applications, the market growth rate for this sub-segment is substantial owing to the ethical issues faced by this sub-segment in the global market.

In terms of Therapeutic Application, the market study encompasses various aspects such ca Regenerative Medicine, Neurological Disorders, Orthopedic Treatments, Oncology Disorders, Diabetes, Injuries & Wounds and Cardiovascular Disorders. Growing awareness regarding regenerative medicine is expected to make this sub-segment hold a potential market share globally. Growing healthcare expenditure and presence of major industry players makes North America hold major share in the global market.

Stem Cells Market Competitive Landscape The Stem Cells Market study report offers a valuable insight with an emphasis on global market including some of the major players such asBioTime Inc., Cytori Therapeutics, Inc., STEMCELL Technologies Inc., Astellas Pharma Inc., U.S. Stem Cell, Inc., Osiris Therapeutics, Inc., Takara Bio Inc., Caladrius Biosciences, Inc., Cellular Engineering Technologies Inc., and BrainStorm Cell Therapeutics Inc. Our market analysis also entails a section solely dedicated for such major players wherein our analysts provide an insight to the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share and market ranking analysis of the above mentioned players globally.

Analyst View: As per our sources following trends were observed in terms of most popular sources of stem cells:

Stem cells from adult bone marrow were observed to be the most popular source. Scope of stem cell therapy is increasing with growing number of applications. Clinical research has advanced to a great magnitude towards preventing, identifying and handling devastating diseases. Various applications of stem cells in regeneration such as Cardiac Regeneration, Hepatic Regeneration, Regeneration of Neural Tissue, etc. have come up lately. This suggests that the market for stem cells will grow significantly over the forecast period.

Research Methodology of Verified Market Research:

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Stem Cells Market Development Status, Emerging Technologies, Regional Trends and Comprehensive Research Study 2025 – The Daily Chronicle

Cell Therapy Manufacturing Market To Experience Significant Growth During The Forecast Period 2020-2029 – Scientect

The research study on Global Cell Therapy Manufacturing market 2019 presents an extensive analysis of current Cell Therapy Manufacturing market size, drivers, trends, opportunities, challenges, as well as key Cell Therapy Manufacturing market segments. Further, it explains various definitions and classification of the Cell Therapy Manufacturing industry, applications, and chain structure.In continuation of this data, the Cell Therapy Manufacturing report covers various marketing strategies followed by key players and distributors. Also explains Cell Therapy Manufacturing marketing channels, potential buyers and development history. The intent of global Cell Therapy Manufacturing research report is to depict the information to the user regarding Cell Therapy Manufacturing market forecast and dynamics for the upcoming years.The Cell Therapy Manufacturing study lists the essential elements which influence the growth of Cell Therapy Manufacturing industry. Long-term evaluation of the worldwide Cell Therapy Manufacturing market share from diverse countries and regions is roofed within the Cell Therapy Manufacturing report. Additionally, includes Cell Therapy Manufacturing type wise and application wise consumption figures.

The Final Report will cover the impact analysis of COVID-19 on this industry.

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After the basic information, the global Cell Therapy Manufacturing Market study sheds light on the Cell Therapy Manufacturing technological evolution, tie-ups, acquisition, innovative Cell Therapy Manufacturing business approach, new launches and Cell Therapy Manufacturing revenue. In addition, the Cell Therapy Manufacturing industry growth in distinct regions and Cell Therapy Manufacturing R&D status are enclosed within the report.The Cell Therapy Manufacturing study also incorporates new investment feasibility analysis of Cell Therapy Manufacturing. Together with strategically analyzing the key micro markets, the report also focuses on industry-specific drivers, restraints, opportunities, and challenges in the Cell Therapy Manufacturing market.

Global Cell Therapy Manufacturing Market Segmentation 2019: The study also classifies the entire Cell Therapy Manufacturing market on basis of leading manufacturers, different types, various applications and diverse geographical regions.Overall Cell Therapy Manufacturing market is characterized by the existence of well-known global and regional Cell Therapy Manufacturing vendors. These established Cell Therapy Manufacturing players have huge essential resources and funds for Cell Therapy Manufacturing research as well as developmental activities. Also, the Cell Therapy Manufacturing manufacturers focusing on the development of new Cell Therapy Manufacturing technologies and feedstock. In fact, this will enhance the competitive scenario of the Cell Therapy Manufacturing industry.

The Leading Players involved in global Cell Therapy Manufacturing market are: harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

Based on Therapy Type, the Cell Therapy Manufacturing market is categorized into: Allogeneic Cell Therapy Autologous Cell Therapy

Based on Technology, the Cell Therapy Manufacturing market is categorized into: Somatic Cell Technology Cell Immortalization Technology Viral Vector Technology Genome Editing Technology Cell Plasticity Technology 3D Technology

Based on Source, the Cell Therapy Manufacturing market is categorized into: IPSCs Bone Marrow Umbilical Cord Adipose Tissue Neural Stem Cells

Based on Application, the Cell Therapy Manufacturing market is categorized into: Musculoskeletal Cardiovascular Gastrointestinal Neurological Oncology Dermatology Other

Global Cell Therapy Manufacturing Market Regional Analysis: The companies in the world that deals with Cell Therapy Manufacturing mainly concentrate following regions. North America, Europe, Asia Pacific, Latin America, and Middle East & Africa Global Cell Therapy Manufacturing Industry Report Covers following Topics: 01: Cell Therapy Manufacturing Market Overview 02: Global Cell Therapy Manufacturing Sales, Revenue (value) and Market Share by Players 03: Cell Therapy Manufacturing Market Sales, Revenue (Value) by Regions, Type and Application (2014-2018) 04: Region wise Top Players Cell Therapy Manufacturing Sales, Revenue and Price 05: worldwide Cell Therapy Manufacturing Industry Players Profiles/Analysis 06: Cell Therapy Manufacturing Cost Analysis 07: Industrial Chain, Cell Therapy Manufacturing Sourcing Strategy and Downstream Buyers 08: Cell Therapy Manufacturing Marketing Strategy Analysis, Distributors/Traders 09: Cell Therapy Manufacturing Industry Effect Factors Analysis 10: Global Cell Therapy Manufacturing Market Forecast (2019-2026) 11: Cell Therapy Manufacturing Research Findings and Conclusion 12: Appendix

Download Sample of This Strategic Report:https://www.kennethresearch.com/sample-request-10225722

Worldwide Cell Therapy Manufacturing Market Different Analysis: Competitors Review of Cell Therapy Manufacturing Market: Report presents the competitive landscape scenario seen among top Cell Therapy Manufacturing players, their company profile, revenue, sales, business tactics and forecast Cell Therapy Manufacturing industry situations. Production Review of Cell Therapy Manufacturing Market: It illustrates the production volume, capacity with respect to major Cell Therapy Manufacturing regions, application, type, and the price.

Sales Margin and Revenue Accumulation Review of Cell Therapy Manufacturing Market: Eventually explains sales margin and revenue accumulation based on key regions, price, revenue, and Cell Therapy Manufacturing target consumer.

Supply and Demand Review of Cell Therapy Manufacturing Market: Coupled with sales margin, the report depicts the supply and demand seen in major regions, among key players and for every Cell Therapy Manufacturing product type. Also interprets the Cell Therapy Manufacturing import/export scenario.

Other key reviews of Cell Therapy Manufacturing Market: Apart from the above information, correspondingly covers the company website, number of employees, contact details of major Cell Therapy Manufacturing players, potential consumers and suppliers. Also, the strengths, opportunities, Cell Therapy Manufacturing market driving forces and market restraints are studied in this report.

Highlights of Global Cell Therapy Manufacturing Market Report: * This report provides in detail analysis of the Cell Therapy Manufacturing and provides market size (US$ Million) and Cumulative Annual Growth Rate (CAGR (%)) for the forecast period: 2019 2029. * It also elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for world Cell Therapy Manufacturing market. * This study also provides key insights about Cell Therapy Manufacturing market drivers, restraints, opportunities, new product launches, approvals, regional outlook, and competitive strategies adopted by the leading Cell Therapy Manufacturing players. * It profiles leading players in the worldwide Cell Therapy Manufacturing market based on the following parameters company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies and future plans. * Insights from Cell Therapy Manufacturing report would allow marketers and management authorities of companies to make an informed decision with respect to their future product launches, market expansion, and Cell Therapy Manufacturing marketing tactics. * The world Cell Therapy Manufacturing industry report caters to various stakeholders in Cell Therapy Manufacturing market. That includes investors, device manufacturers, distributors and suppliers for Cell Therapy Manufacturing equipment. Especially incorporates government organizations, Cell Therapy Manufacturing research and consulting firms, new entrants, and financial analysts. *Various strategy matrices used in analyzing the Cell Therapy Manufacturing market would provide stakeholders vital inputs to make strategic decisions accordingly. Global Cell Therapy Manufacturing Market Report Provides Comprehensive Analysis of Following: Cell Therapy Manufacturing Market segments and sub-segments Industry size & Cell Therapy Manufacturing shares Cell Therapy Manufacturing Market trends and dynamics Market Drivers and Cell Therapy Manufacturing Opportunities Supply and demand of world Cell Therapy Manufacturing industry Technological inventions in Cell Therapy Manufacturing trade Cell Therapy Manufacturing Marketing Channel Development Trend Global Cell Therapy Manufacturing Industry Positioning Pricing and Brand Strategy Distributors/Traders List enclosed in Positioning Cell Therapy Manufacturing Market.

Request For Full Report:https://www.kennethresearch.com/sample-request-10225722

Moreover, the report organizes to provide essential information on current and future Cell Therapy Manufacturing market movements, organizational needs and Cell Therapy Manufacturing industrial innovations. Additionally, the complete Cell Therapy Manufacturing report helps the new aspirants to inspect the forthcoming opportunities in the Cell Therapy Manufacturing industry. Investors will get a clear idea of the dominant Cell Therapy Manufacturing players and their future forecasts.

About Kenneth Research:

Kenneth Research provides market research reports to different individuals, industries, associations and organizations with an aim of helping them to take prominent decisions. Our research library comprises of more than 10,000 research reports provided by more than 15 market research publishers across different industries. Our collection of market research solutions covers both macro level as well as micro level categories with relevant and suitable market research titles. As a global market research reselling firm, Kenneth Research provides significant analysis on various markets with pure business intelligence and consulting services on different industries across the globe. In addition to that, our internal research team always keep a track on the international and domestic market for any economic changes impacting the products demand, growth and opportunities for new and existing players.

Contact Us

Kenneth Research Email: [emailprotected] Phone: +1 313 462 0609

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Cell Therapy Manufacturing Market To Experience Significant Growth During The Forecast Period 2020-2029 – Scientect

Cell Therapy Manufacturing Market 2020 Report Including COVID-19 Impact Analysis and Forecast till 2029 – Scientect

The research study on Global Cell Therapy Manufacturing market 2019 presents an extensive analysis of current Cell Therapy Manufacturing market size, drivers, trends, opportunities, challenges, as well as key Cell Therapy Manufacturing market segments. Further, it explains various definitions and classification of the Cell Therapy Manufacturing industry, applications, and chain structure.In continuation of this data, the Cell Therapy Manufacturing report covers various marketing strategies followed by key players and distributors. Also explains Cell Therapy Manufacturing marketing channels, potential buyers and development history. The intent of global Cell Therapy Manufacturing research report is to depict the information to the user regarding Cell Therapy Manufacturing market forecast and dynamics for the upcoming years.The Cell Therapy Manufacturing study lists the essential elements which influence the growth of Cell Therapy Manufacturing industry. Long-term evaluation of the worldwide Cell Therapy Manufacturing market share from diverse countries and regions is roofed within the Cell Therapy Manufacturing report. Additionally, includes Cell Therapy Manufacturing type wise and application wise consumption figures.

The Final Report will cover the impact analysis of COVID-19 on this industry.

Download Sample of This Strategic Report:https://www.kennethresearch.com/sample-request-10225722

After the basic information, the global Cell Therapy Manufacturing Market study sheds light on the Cell Therapy Manufacturing technological evolution, tie-ups, acquisition, innovative Cell Therapy Manufacturing business approach, new launches and Cell Therapy Manufacturing revenue. In addition, the Cell Therapy Manufacturing industry growth in distinct regions and Cell Therapy Manufacturing R&D status are enclosed within the report.The Cell Therapy Manufacturing study also incorporates new investment feasibility analysis of Cell Therapy Manufacturing. Together with strategically analyzing the key micro markets, the report also focuses on industry-specific drivers, restraints, opportunities, and challenges in the Cell Therapy Manufacturing market.

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Global Cell Therapy Manufacturing Market Segmentation 2019: The study also classifies the entire Cell Therapy Manufacturing market on basis of leading manufacturers, different types, various applications and diverse geographical regions.Overall Cell Therapy Manufacturing market is characterized by the existence of well-known global and regional Cell Therapy Manufacturing vendors. These established Cell Therapy Manufacturing players have huge essential resources and funds for Cell Therapy Manufacturing research as well as developmental activities. Also, the Cell Therapy Manufacturing manufacturers focusing on the development of new Cell Therapy Manufacturing technologies and feedstock. In fact, this will enhance the competitive scenario of the Cell Therapy Manufacturing industry.

The Leading Players involved in global Cell Therapy Manufacturing market are: harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

Based on Therapy Type, the Cell Therapy Manufacturing market is categorized into: Allogeneic Cell Therapy Autologous Cell Therapy

Based on Technology, the Cell Therapy Manufacturing market is categorized into: Somatic Cell Technology Cell Immortalization Technology Viral Vector Technology Genome Editing Technology Cell Plasticity Technology 3D Technology

Based on Source, the Cell Therapy Manufacturing market is categorized into: IPSCs Bone Marrow Umbilical Cord Adipose Tissue Neural Stem Cells

Based on Application, the Cell Therapy Manufacturing market is categorized into: Musculoskeletal Cardiovascular Gastrointestinal Neurological Oncology Dermatology Other

Global Cell Therapy Manufacturing Market Regional Analysis: The companies in the world that deals with Cell Therapy Manufacturing mainly concentrate following regions. North America, Europe, Asia Pacific, Latin America, and Middle East & Africa Global Cell Therapy Manufacturing Industry Report Covers following Topics: 01: Cell Therapy Manufacturing Market Overview 02: Global Cell Therapy Manufacturing Sales, Revenue (value) and Market Share by Players 03: Cell Therapy Manufacturing Market Sales, Revenue (Value) by Regions, Type and Application (2014-2018) 04: Region wise Top Players Cell Therapy Manufacturing Sales, Revenue and Price 05: worldwide Cell Therapy Manufacturing Industry Players Profiles/Analysis 06: Cell Therapy Manufacturing Cost Analysis 07: Industrial Chain, Cell Therapy Manufacturing Sourcing Strategy and Downstream Buyers 08: Cell Therapy Manufacturing Marketing Strategy Analysis, Distributors/Traders 09: Cell Therapy Manufacturing Industry Effect Factors Analysis 10: Global Cell Therapy Manufacturing Market Forecast (2019-2026) 11: Cell Therapy Manufacturing Research Findings and Conclusion 12: Appendix

Download Sample of This Strategic Report:https://www.kennethresearch.com/sample-request-10225722

Worldwide Cell Therapy Manufacturing Market Different Analysis: Competitors Review of Cell Therapy Manufacturing Market: Report presents the competitive landscape scenario seen among top Cell Therapy Manufacturing players, their company profile, revenue, sales, business tactics and forecast Cell Therapy Manufacturing industry situations. Production Review of Cell Therapy Manufacturing Market: It illustrates the production volume, capacity with respect to major Cell Therapy Manufacturing regions, application, type, and the price.

Sales Margin and Revenue Accumulation Review of Cell Therapy Manufacturing Market: Eventually explains sales margin and revenue accumulation based on key regions, price, revenue, and Cell Therapy Manufacturing target consumer.

Supply and Demand Review of Cell Therapy Manufacturing Market: Coupled with sales margin, the report depicts the supply and demand seen in major regions, among key players and for every Cell Therapy Manufacturing product type. Also interprets the Cell Therapy Manufacturing import/export scenario.

Other key reviews of Cell Therapy Manufacturing Market: Apart from the above information, correspondingly covers the company website, number of employees, contact details of major Cell Therapy Manufacturing players, potential consumers and suppliers. Also, the strengths, opportunities, Cell Therapy Manufacturing market driving forces and market restraints are studied in this report.

Highlights of Global Cell Therapy Manufacturing Market Report: * This report provides in detail analysis of the Cell Therapy Manufacturing and provides market size (US$ Million) and Cumulative Annual Growth Rate (CAGR (%)) for the forecast period: 2019 2029. * It also elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for world Cell Therapy Manufacturing market. * This study also provides key insights about Cell Therapy Manufacturing market drivers, restraints, opportunities, new product launches, approvals, regional outlook, and competitive strategies adopted by the leading Cell Therapy Manufacturing players. * It profiles leading players in the worldwide Cell Therapy Manufacturing market based on the following parameters company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies and future plans. * Insights from Cell Therapy Manufacturing report would allow marketers and management authorities of companies to make an informed decision with respect to their future product launches, market expansion, and Cell Therapy Manufacturing marketing tactics. * The world Cell Therapy Manufacturing industry report caters to various stakeholders in Cell Therapy Manufacturing market. That includes investors, device manufacturers, distributors and suppliers for Cell Therapy Manufacturing equipment. Especially incorporates government organizations, Cell Therapy Manufacturing research and consulting firms, new entrants, and financial analysts. *Various strategy matrices used in analyzing the Cell Therapy Manufacturing market would provide stakeholders vital inputs to make strategic decisions accordingly. Global Cell Therapy Manufacturing Market Report Provides Comprehensive Analysis of Following: Cell Therapy Manufacturing Market segments and sub-segments Industry size & Cell Therapy Manufacturing shares Cell Therapy Manufacturing Market trends and dynamics Market Drivers and Cell Therapy Manufacturing Opportunities Supply and demand of world Cell Therapy Manufacturing industry Technological inventions in Cell Therapy Manufacturing trade Cell Therapy Manufacturing Marketing Channel Development Trend Global Cell Therapy Manufacturing Industry Positioning Pricing and Brand Strategy Distributors/Traders List enclosed in Positioning Cell Therapy Manufacturing Market.

Request For Full Report:https://www.kennethresearch.com/sample-request-10225722

Moreover, the report organizes to provide essential information on current and future Cell Therapy Manufacturing market movements, organizational needs and Cell Therapy Manufacturing industrial innovations. Additionally, the complete Cell Therapy Manufacturing report helps the new aspirants to inspect the forthcoming opportunities in the Cell Therapy Manufacturing industry. Investors will get a clear idea of the dominant Cell Therapy Manufacturing players and their future forecasts.

About Kenneth Research:

Kenneth Research provides market research reports to different individuals, industries, associations and organizations with an aim of helping them to take prominent decisions. Our research library comprises of more than 10,000 research reports provided by more than 15 market research publishers across different industries. Our collection of market research solutions covers both macro level as well as micro level categories with relevant and suitable market research titles. As a global market research reselling firm, Kenneth Research provides significant analysis on various markets with pure business intelligence and consulting services on different industries across the globe. In addition to that, our internal research team always keep a track on the international and domestic market for any economic changes impacting the products demand, growth and opportunities for new and existing players.

Contact Us

Kenneth Research Email: [emailprotected] Phone: +1 313 462 0609

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Cell Therapy Manufacturing Market 2020 Report Including COVID-19 Impact Analysis and Forecast till 2029 – Scientect

Cell Therapy Market Opportunities, Threats, Trends, Applications, And Growth Forecast To 2027 | MEDIPOST, Osiris Therapeutics, NuVasive, Cells for…

A new market report by The Insight Partners on the Cell Therapy Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets.

Cell therapy (CT) is the process of transplanting human cells to replace or repair damaged tissue or cells. Various methods can be used to carry out cell therapy. For instance, hematopoietic stem cell transplantation, also known as bone marrow transplant, is the most widely used cell therapy. It is used to treat a variety of blood cancers and blood-related conditions.

Get Sample PDF of at: https://www.theinsightpartners.com/sample/TIPRE00009666/

Key companies Included in Cell Therapy Market:-

Kolon TissueGene, Inc. MEDIPOST JCR Pharmaceuticals Co. Ltd. Stemedica Cell Technologies, Inc. Osiris Therapeutics, Inc. NuVasive, Inc. Fibrocell Science, Inc. Vericel Corporation Cells for Cells Celgene Corporation

The global cell therapy market is segmented on the basis of therapy type, product, technology, application, end user. Based on the therapy type the market is classified as autologous, and allogeneic. Based on product the market is segmented as equipment, consumables, software and services. Based on technology the market is segmented as somatic cell technology, cell immortalization technology, viral vector technology, genome editing technology, cell plasticity technology, and three-dimensional technology. Based on application the market is classified as oncology, cardiology, orthopedic, wound management and others. And based on end user the market is divided into hospitals, regenerative medicine centers, and research institutes.

The report offers key drivers that propel the growth in the global Cell Therapy Market. These insights help market players in devising strategies to gain market presence. The research also outlined the restraints of the market. Insights on opportunities are mentioned to assist market players in taking further steps by determining the potential in untapped regions.

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Cell Therapy Market which would mention How the Covid-19 is Affecting the Disposable Incontinence Products (DIPs) Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Disposable Incontinence Products (DIPs) Players to fight Covid-19 Impact.

Cell Therapy Market: Regional analysis includes:

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The Insight Partners is a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We are a specialist in Life Science, Technology, Healthcare, Manufacturing, Automotive and Defense, Food Beverages, Chemical etc.

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Cell Therapy Market Opportunities, Threats, Trends, Applications, And Growth Forecast To 2027 | MEDIPOST, Osiris Therapeutics, NuVasive, Cells for…

Outlook on the Worldwide Hunter Syndrome Industry to 2030 – ResearchAndMarkets.com – Yahoo Finance

The “Hunter Syndrome – Market Insights, Epidemiology and Market Forecast – 2030” drug pipelines has been added to ResearchAndMarkets.com’s offering.

This report delivers an in-depth understanding of the Hunter Syndrome, historical and forecasted epidemiology as well as the Hunter Syndrome market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Hunter Syndrome market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Hunter Syndrome market size from 2017 to 2030. The report also covers current Hunter Syndrome treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Hunter Syndrome Diagnosis

The diagnosis of Hunter syndrome is established in a male by identifying the deficient iduronate 2-sulfatase (I2S) enzyme activity in white cells, fibroblasts, or plasma in the presence of normal activity of at least one other sulfatase. Detection of a hemizygous pathogenic variant in IDS confirms the diagnosis in a male with an unusual phenotype or a phenotype that does not match the results of GAG testing. The diagnosis of this indication is usually established in a female with suggestive clinical features by identification of a heterozygous IDS pathogenic variant on molecular genetic testing.

Although the disease is almost exclusively reported in males, rare cases in females also do occur. The diagnosis of MPS II is usually established in a female patient with suggestive clinical features, such as the identification of a heterozygous IDS pathogenic variant on molecular genetic testing.

Molecular genetic testing approaches can include a combination of gene-targeted testing (single-gene testing, multigene panel) and comprehensive genomic testing (exome sequencing, genome sequencing) depending on the phenotype. Gene-targeted testing requires that the clinician determine which gene(s) are likely involved, whereas genomic testing does not.

Hunter Syndrome Treatment

Even with the introduction of ERT, patients with MPS II still require supportive symptomatic treatment from a wide range of specialists. A comprehensive initial assessment of each patient at diagnosis should, therefore, be undertaken, and should be followed by regular reviews. Supportive management and the anticipation of possible complications can greatly improve the quality of life of affected individuals and their families. Family members should be offered genetic counselling, and contact with other affected families, patients, and support groups.

It is now a decade since ERT with intravenous idursulfase (Elaprase), a recombinant form of human iduronate 2-sulfatase, has been approved in the United States and the European Union at a weekly dose of 0.5 mg/kg for the treatment of MPS II. The approval was mainly based on the results from a first trial on individuals with the slowly progressive form of the disease. In the following year several other studies were undertaken to investigate clinical safety and efficacy of ERT; these clearly showed that idursulfase has positive effects on functional capacity (distance walked in six minutes and forced vital capacity), liver and spleen volumes, and urine GAGs excretion. Recently, a 3.5-year independent study determined that long-term use of ERT is similarly effective in young (age 1.6-12 years at the start of ERT) and older individuals (age 12-27 years at the start of ERT). In addition, two recent studies have confirmed ERT efficacy in improving somatic signs and symptoms of the disease in all individuals, including infants younger than age 1 year and individuals with the early progressive MPS II phenotype.

Pretreatment with anti-inflammatory drugs or antihistamines, as is often done for ERT in other conditions, is not suggested on the label for Elaprase; however, if mild or moderate infusion reactions (e.g., dyspnea, urticaria, or systolic blood pressure changes of 20 mm Hg) cannot be ameliorated by slowing the infusion rate, the addition of treatment one hour before infusion with diphenhydramine and acetaminophen (or ibuprofen) to the regimen usually resolves the problem. Pretreatment can typically be discontinued after 6-10 weeks.

Story continues

Hematopoietic stem cell transplantation (HSCT) using umbilical cord blood or bone marrow is a potential way of providing sufficient enzyme activity to slow or stop the progression of the disease, however, the use of HSCT is controversial because of the associated high risk of morbidity and mortality. The use of HSCT has been controversial because of limited information regarding the long-term outcomes and the associated high risk of morbidity and mortality.

Scope of the Report

Reasons to Buy

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Contacts

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Outlook on the Worldwide Hunter Syndrome Industry to 2030 – ResearchAndMarkets.com – Yahoo Finance

Edited Transcript of CLDX.OQ earnings conference call or presentation 6-Aug-20 8:30pm GMT – Yahoo Finance

NEEDHAM Aug 7, 2020 (Thomson StreetEvents) — Edited Transcript of Celldex Therapeutics Inc earnings conference call or presentation Thursday, August 6, 2020 at 8:30:00pm GMT

* Anthony S. Marucci

Celldex Therapeutics, Inc. – Founder, President, CEO & Director

Celldex Therapeutics, Inc. – SVP of Regulatory Affairs

Celldex Therapeutics, Inc. – Senior VP, CFO, Secretary & Treasurer

Celldex Therapeutics, Inc. – SVP of Corporate Affairs & Administration

Welcome to the Celldex Therapeutics Mid-Year 2020 Conference Call. My name is James and I’ll be your operator for today’s call. (Operator Instructions).

And then I’d like to turn the call over to Sarah Cavanaugh. Sarah, you may begin.

Sarah Cavanaugh, Celldex Therapeutics, Inc. – SVP of Corporate Affairs & Administration [2]

Thank you very much. Good afternoon and thank you all for joining us.

With me on the call today are Anthony Marucci, co-founder, President and CEO of Celldex, Dr. Tibor Keler, co-founder Executive Vice President and Chief Scientific Officer, Dr Diane Young, Senior Vice President and Chief Medical Officer. Sam Martin, Senior Vice President and Chief Financial Officer, Dr Margo Heath-Chiozzi, Senior Vice President of Regulatory and Dr Diego Alvarado, Senior Director of Research.

Before we begin our discussion, I’d like to mention that today’s speakers will be making forward-looking statements. Such statements reflect on current views with respect to future events and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Certain of the factors that might cause Celldex’s actual results to differ materially from those in the forward-looking statements, include those set forth under the headings Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operation in Celldex’s annual report on Form 10-K, quarterly reports on Form 10-Q and its current reports on Form 8-K as well as those described in Celldex’s other filings with the SEC and its press releases.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should carefully review all of these factors and be aware that there may be other factors that could cause these differences. These forward-looking statements are based on information, plans and estimates as of this call, and Celldex does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.

Please be advised that the question and answer period will be held at the close of the call. I’d also like to mention that because of the current COVID-19 situation and also two of our offices are located in the areas of the hurricane, we do have folks dialing in from a number of different remote locations and I ask that you may be bear with us phone lines are a little scratchy because we’re dealing with multiple issues on that end.

So with that, I’d like to turn the call over to Anthony. Anthony?

Anthony S. Marucci, Celldex Therapeutics, Inc. – Founder, President, CEO & Director [3]

——————————————————————————–

Thank you, Sarah. Good afternoon everyone and thank you for joining us. We hope you are all safe and healthy and appreciate you’re taking the time to connect with us today. We are looking forward to updating all of you on our progress and providing more detail on our plans for the future. I want to take a few minutes to review the recent events and then I will ask Diane to update you on our clinical programs and Sam to review the financials. We will close the call with your questions.

As you may likely know in early June of this year, Dr Marcus Maurer a leading medical expert in Urticaria, whose research focuses on mast cells presented data from our KIT inhibitor, CDX-0159 and a late breaking session at the EAACI Annual Congress. These data provided an important proof of concept for the program and suggested significant potential which will dramatically impact mast cell driven disorders. These data also help support the $150 million public offering driven by high quality healthcare investors. Importantly, these proceeds will fund the company through 2023 and a number of very important milestones. We are on track to initiate two studies of CDX-0159 and chronic urticaria this fall and I have completed considerable work that Diane will discuss the support expanded development in 2021 and beyond.

As we have always done, we believe is important to focus our resources of people and financial on the programs that hold the most promise for patients and shareholders. Based on the current data we have in-house, we have prioritized the development of our KIT inhibitor CDX-0159, our CDX agonist, CDX-1140 and the first candidate from our bispecific program CDX-527 which combines our proprietary CD-27 agonist with the PD-1 blockade. In turn, we have made a decision not to advance our ErbB3 inhibitor, CDX-3379, which has been in an exploratory study with cetuximab to assess the utility of biomarkers for patient selection and cetuximab resistant head and neck cancer. Despite prophylactic treatment which Diane will discuss in more detail, patients continue to have difficulty tolerating therapy and we believe our resources are best utilized to expand the development of CDX- 0159 and our other pipeline programs.

For our CDX-0159 program, we intend to start two urticaria studies, one in inducible urticaria and the other in spontaneous urticaria this fall and to initiate both the Phase 1 study of CDX- 527 and refractory advanced cancers as well as the combination cohort of CDX-1140 with chemotherapy and treatment of naive metastatic pancreatic cancer later this year. This program is all support multiple data readouts later this year and next year including results from the CDX-0159 study and inducible urticaria in the first quarter of 2021 and the results from the study in spontaneous urticaria in the second half of next year.

We are also in the midst of a thorough assessment of additional opportunities for CDX-0159 and as we now of this list, we plan to initiate our third study and another mast cell driven disease next summer.

With this introduction, I would like Diane to cover activities in more detail. Diane?

——————————————————————————–

Diane C. Young, [4]

——————————————————————————–

Thank you, Anthony. Let me start with CDX-0159. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds to the KIT receptor with high specificity and potently inhibits it’s activity. The KIT receptor tyrosine kinase is expressed in mast cells which mediate inflammatory responses such as hypersensitivity an allergic reaction. Ultimately, KIT signaling controls the differentiation, tissue recoupment, survival and activity of mast cells and we believe targeting KIT represents a unique strategy in diseases involving mast cells.

At the EAACI meetings, results from our recently completed Phase 1A study in healthy volunteers were presented. CDX -0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, a protease made almost exclusively by mast cells. The phase 1A study was a randomized double blind, placebo-controlled single-ascending dose escalation study of CDX-0159 in 32 healthy subjects.

Subjects received a single intravenous infusion of CDX-0159 at 0.31319 milligrams per kilogram or placebo. As Dr. Maurer presented a single dose of CDX-0159 supress plasma tryptase levels in a dose-dependent manner indicative of systemic mast cell suppression or ablation, tryptase reduction was evident at 24 hours after infusions and minimal levels were typically observed within one week. Tryptase suppression below the level of detection was observed after a single one milligram per kilogram dose and was maintained for more than two months at single doses of both 3 and 9 milligrams per kilogram.

A subset of subjects from the 3 milligram per kilogram and 9 milligrams per kilogram cohorts agreed to continued follow-up For tryptase analysis which was ongoing at the time of the EAACI meeting. This follow-up and analysis was completed in July and tryptase levels remain below the level of detection for 14 weeks in the 3 milligram per kilogram cohorts for 50% of the returning subjects and 18 weeks in the 9 milligrams per kilogram cohort for all returning subjects. In this study, dose-dependent increases in plasma stem cell factor also mere decreases in tryptase consistent with allosteric blockade of stem cell factor to KIT and further demonstrating complete target engagement in vivo.

Importantly, CDX-0159 also demonstrated a favorable safety profile. The most common adverse events were mild infusion related reactions which spontaneously resolved without intervention. Asymptomatic decreases in neutrophil and white blood cell counts were also observed in laboratory testings but we returning towards normal at the end of the study. We also observed long serum half-life and lack of anti-drug antibodies which provide support to explore less frequent dosing in future studies. Based on these results, we plan to initiate 2 Phase 1B studies of CDX-0159 this fall, one in chronic inducible urticaria and one in chronic spontaneous urticaria, both of which are mast cell driven diseases specifically selected to provide clinical proof of concept for CDX-0159. I’ll start with the study in the inducible urticaria as this indication will read out first with data expected in the first quarter of next year.

There were multiple forms of inducible urticaria and 0.5% of the total population suffer from them. We have selected two of the most common forms: symptomatic dermagraftism and cold-induced urticaria. Symptomatic dermagraftism is characterized by the development of a wheel and flare reaction in response to a stroking, scratching or rubbing of the skin usually occurring within minutes of the inciting stimulus. People afflicted with cold-induced urticaria experienced symptoms like itching, burning wheels and angioedema where their skin comes in contact with temperatures below skin temperature. For both of these diseases mast cell activation, leading to release of soluble mediators is thought to be the driving mechanism leading to the wheels and other symptom.

As you can tell based on their name, what’s unique about these indications Is that they are induced by certain triggers and importantly investigators can induce these same reactions in the clinic. Dr Maurer will lead this study in his specialty clinic for urticaria in Berlin. We expect to enroll 20 patients, ten with symptomatic dermagraftism and ten with cold-induced urticaria who are resistant to antihistamine treatment. Their symptoms will be introduced in the clinic and a single dose of CDX-0159 at 3 milligram per kilogram will be administered. Patients will be followed for 12 weeks to evaluate safety and tolerability, clinical activity and pharmacokinetics and pharmacodynamics. Importantly, we intend to perform serial skin biopsies on patients so we can explore the impact of CDX-0159 on mast cells in the skin. This will help address whether CDX-0159 is inactivating the mast cells or leading to their deaths in elimination from skin.

The second study will be in chronic spontaneous urticaria or CSU, an indication where patients experience urticaria symptoms without identification of a known cause. This is a disease driven by mast cell activation, the release of mediators resulting episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades. It is one of the most frequent dermatologic diseases with the prevalence of 0.5% to 1% of the total population and up to 3.2 million cases annually in the US. The study will be a randomized, double-blind, placebo-controlled Phase 1B dose escalation study that includes patients who are still symptomatic despite antihistamine therapy. We expect to enroll 40 patients across four cohorts, who will receive CDX-0159 or placebo. The dose and dosing schedule will vary by cohort.

Patients dosed at 0.5 and 1.5 milligram per kilogram will receive three doses at 4-week intervals and patients dosed at 3 and 4.5 milligrams per kilogram will receive two doses at an 8-week interval. The 12-week treatment period will be followed by another 12 weeks of follow-up. So 24 weeks total. This design will provide necessary data on the safety of multiple doses and also allow us to evaluate the potential clinical activity of CDX-0159 in this patient population. Again, we will be evaluating safety and tolerability, symptomatic relief as measured through disease activity scores and pharmacokinetics and pharmacodynamics. The study will be conducted at 4 to 5 centers in the USA, beginning in the fall of 2020. We anticipate results from this study in the second half of next year.

For both inducible and spontaneous urticaria, it is clear that these patients can truly suffer. The two top complaints are constant intense itch and poor self image. Their symptoms prevent regular sleep, interfere with daily life and work activities which subsequently promote social withdrawal, isolation and depression. There is truly an unmet need for efficacious therapies that address the root cause of their disease, mast cells.

Beyond urticaria, there are many diseases in which mast cells are the principal driver or a thought to significantly contribute to the pathology. We are digging deeply into the potential opportunity for CDX-0159 in these indications to select additional areas for expansion. Our evaluation includes review of scientific literature, medical guidelines, regulatory documents and market analyzes and discussions with medical experts. We are prioritizing indications in which there is strong evidence that mast cells play an important role in pathophysiology where there are unmet medical needs and where we can envision a clinical development path with clear early decision point.

We have narrowed what began as a list of over 50 indications to 4 major areas of focus. Mast cell activation syndromes including mastocytosis, Asthma including severe forms of asthma, allergic asthma and exercise induced asthma, allergic conditions including food allergies and allergy mediated dermatologic conditions and mast cell driven gastrointestinal disorders.

Our next step is to lay out the clinical development and regulatory path as well as commercial opportunities to help in the final indication selection. We will also be monitoring the field closely to ensure our plans continually reflect all available scientific clinical regulatory and competitive data. Certainly as data begin to emerge from the urticaria studies, this will also inform our final decision. We will continue to update you as we complete our diligent but are confident we will be in a position to initiate a Phase 1B-2 study in a third indication by summer 2021.

Finally, in closing for CDX-0159 I want to point out that we have initiated formulation work for subcutaneous delivery which we believe will be important to the candidates future success. We believe we are well positioned given CDX-0159 and enhanced PK profile and the durable tryptase suppression we observed even at low doses. The preliminary feasibility studies at 150 milligrams per mill look promising.

With that overview on CDX-0159, let me turn now to CDX 1140 and CDX-527. CDX-1140 is a Celldex developed human agonist anti-CD-40 monoclonal antibody that was specifically designed to balance good systemic exposure and safety with potent biological activity a profile, which differentiates CDX-1140 from other CD-40 activating antibodies for systemic therapy. CD-40 expressed on dendritic cells and other antigen presenting cells is an important target for Immunotherapy as it plays a critical role in the activation of innate and adaptive immune responses.

CDX-1140 completed dose escalation as monotherapy and in combination with CDX-301 a dendritic cell growth factor in an ongoing Phase 1 study in patients with recurrent, locally advanced or metastatic solid tumors and B-cell lymphomas. A critical goal of this study was to achieve dosing levels that provide good systemic exposure without dose limiting toxicity. As reported at the SITC meeting last November, CDX-1140 reach this goal with the maximum tolerated dose and recommended Phase 2 dose of 1.5 milligrams per kilogram, one of the highest systemic dose levels in the CD-40 agonist class.

We believe the relatively low doses of other potent CD-40 agonist antibodies tested in the clinic to date may limit their potential and modifying in the tumor micro environment and are hopeful that CDX-1140 at this dose level will better penetrate tumor and be more impactful. Importantly, from a safety perspective at 1.5 milligram per kilogram CDX-1140 is associated with manageable immune related adverse events that are consistent with those observed with approved effective therapies like checkpoint inhibitors.

While CDX-1140 has shown promising signs of single agent activity, it’s clear that the combination approaches that target multiple pathways in the immune system likely offer patients the best opportunities for improvement. To that end, we have added multiple combination expansion cohorts including with KEYTRUDA in patients who have progressed on checkpoint therapy and with CDX-301 in patients with head and neck squamous cell carcinoma.

We also expect to initiate a combination with standard of care chemotherapy in first-line metastatic pancreatic cancer later this year. An indication, we are very interested in because both preclinical and clinical data suggests that the CD-40 pathway may have important anti-tumor potential in this disease.

We also expect to report on interim data from CDX-1140 this fall, that would focus on data from the monotherapy expansion cohorts in squamous cell head and neck cancer and renal cell carcinoma, data from the combination with CDX-301 and preliminary data from the combination with KEYTRUDA.

CDX-527, our first bispecific antibody program is also expected to enter the clinic later this year. CDX-527 combines CD-27 mediated T-cell activation with PD-1 blockade. We have developed CDX-527 from our proprietary highly active PDL-1 and CD-27 human antibodies and demonstrated the bispecific to be more potent than the combination of the individual antibodies in preclinical models.

Importantly, our prior clinical experience combining the CD27 agonist antibody varlilumab with PD-1 blockade supports the integration of these two antibodies from a dosing safety and activity perspective. We would expect initial data from this program in the first half of 2021.

Before I turn the call over to Sam to discuss the financials, I want to provide a little more clinical context surrounding the decision on CDX-3379 development.

At ASCO 2019, we presented a retrospective analysis that suggested that the anti-tumor activity with CDX-3379 might be associated with somatic mutations in particular genes associated with tumor suppression.

We decided to examine this hypothesis in an exploratory manner in the ongoing trial to see if there was a path forward that would allow us to utilize biomarkers to identify a targeted population that would respond to CDX-3379. In parallel, we knew that we needed to improve the tolerability of the combination of CDX-3379 and cetuximab specifically diarrhea management. Unfortunately, despite diarrhea prophylaxis measures, this continue to be a side effect which in addition to severe skin rash caused dose reductions and delays in the majority of patients, making it difficult to achieve clinical benefit. When considered together and after talking to our study investigators, we believe the risk benefit profile does not support further development in patients and that the resources allocated to this program would be best focused on expanded development of CDX-0159 CDX-1140 and CDX-527.

We will also continue to advance our preclinical pipeline which is exploring several interesting targets including AXL IoT-4, CD 24 and cyclic-15. Updates on our preclinical programs will be presented at scientific meetings later this year and next.

In summary, we are very pleased with the progress we’ve made so far this year. We believe CDX-0159 has the potential to be a field changing product across multiple mast cell driven indications and that CDX-1140 is establishing itself as a clearly differentiated CD-40 agonist. We’re excited to bring CDX 527 into the clinic and all combined, look forward to a very busy rest of 2020.

We continue to be mindful of COVID-19 and our partnering closely with our clinical trial sites to mitigate any COVID related impact on our studies. So far. we have been very successful in these efforts but like everyone else we are looking cautiously at this fall and winter and contingency planning to help mitigate any risk to our timeline.

With that, I thank you for your time and I will hand the call over to Sam to review the financials. Sam?

——————————————————————————–

Sam Martin, Celldex Therapeutics, Inc. – Senior VP, CFO, Secretary & Treasurer [5]

——————————————————————————–

Thank you, Diane. For the second quarter of 2020 net loss was $11 million or $0.50 per share compared to a net loss of $11.8 million or $0.84 per share for the second quarter of 2019. Net loss for the six months ended June 30, 2020 was $23.7 million or $1.20 per share compared to 29 million or $2.21 per share for the comparable period in 2019.

Research and development expenses were $21.4 million for the six months ended June 30, 2020 compared to $21.2 million for the comparable period in 2019.

General and administrative expenses were $7.2 million for the six months ended June 30, 2020 compared to $8.8 million for the comparable period in 2019.

As of June 30, 2020, we reported cash, cash equivalents and marketable securities of $206.9 million compared to $53.7 million as of March 31, 2020. The increase was primarily driven by net proceeds of $141.4 million from our June 2020 underwritten public offering and net proceeds of $23.7 million from sales of common stock under our controlled equity offering agreement with Cantor completed in the second quarter prior to the public offering in June.

These increases were offset by second quarter cash used in operating activities of $11.2 million. We expect the cash, cash equivalents and marketable securities at June 30, 2020 are sufficient to meet estimated working capital requirements and fund planned operations through 2023. At June 30, 2020 we had 39.1 million shares outstanding.

I will now turn the call over to Anthony to close.

——————————————————————————–

Anthony S. Marucci, Celldex Therapeutics, Inc. – Founder, President, CEO & Director [6]

——————————————————————————–

Thank you, Sam and thank you all for joining us today. To recap, as always, we remain focused on the successful development of our clinical programs.

We look forward to initiating the 2 Phase 1B studies of CDX-0159 this fall and the Phase 1 study of CDX-527 and the CDX-1140 expansion cohort later this year, followed by the third study of CDX-0159 in an additional mast cell indication next summer.

For data readouts, we plan to present data update for the CDX-1140 program later this year. in 2021, we anticipate data from the CDX-0159 study in chronic inducible urticaria in the first quarter, data from CDX-527 in the first half and the data from CDX-0159 study and the chronic spontaneous urticaria study in the second half of the year.

I would also anticipate data from the CDX-1140 combination with KEYTRUDA and other expansion cohorts in 2021. As Sam said, we are well capitalized to complete the studies necessary to reach these milestones and and for that, I’d like to thank the investors that participated in our recent financing. We look forward to keeping you all up to date as we continue our progress on these programs.

With that review, we will open the floor to questions. operator?

================================================================================

Questions and Answers

——————————————————————————–

Operator [1]

——————————————————————————–

Thank you. We begin our question and answer session. (Operator Instructions) and our first question comes from Kristen Kluska of Cantor Fitzgerald.

.

——————————————————————————–

Kristen Brianne Kluska, Cantor Fitzgerald & Co., Research Division – Analyst [2]

——————————————————————————–

Hi, everyone. Thanks for taking my questions and congrats on the great progress that you’ve made over this past quarter. So the first question is for the CDS-0159 program, given that some of these patients are likely to have co-morbidities, I’m wondering if you might think these are worth evaluating in the background in either or both the Phase 1B and Phase 2 studies to provide any early proof of effect? Given these indications could also be mast cell driven.

——————————————————————————–

Anthony S. Marucci, Celldex Therapeutics, Inc. – Founder, President, CEO & Director [3]

——————————————————————————–

Sure, Kristen. Thanks. This is Anthony, I’ll have Diane answer that question.

——————————————————————————–

Diane C. Young, [4]

——————————————————————————–

Yes. So that’s an excellent- very good point Kristen. There is a lot of overlap and other conditions that overlap that there may also be impacted. So that is our intention to — even in those early studies to try to capture what other co-morbidities the patients have and to try to with that response in some way.

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Kristen Brianne Kluska, Cantor Fitzgerald & Co., Research Division – Analyst [5]

——————————————————————————–

Great, thank you. And then as it relates to choosing the third mast cells you have an indicating studies in the summer of next year, I wanted to ask if you think the results from the CINDU trial in the first quarter of next year will in any way help determine which one you ultimately choose as the third indication.

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Diane C. Young, [6]

——————————————————————————–

Yes. So I think we’ll definitely take the data from the CINDU study that’s going to give us information about how we’re impacting mast cells and some ideas of dose and duration of clinical effect. So I think that will definitely help to inform what we do next year.

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Edited Transcript of CLDX.OQ earnings conference call or presentation 6-Aug-20 8:30pm GMT – Yahoo Finance

Gene Therapy Market By Industry Type, By Brand And Major Players 2020-2027 – Market Research Posts

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Gene Therapy Market By Industry Type, By Brand And Major Players 2020-2027 – Market Research Posts

CAREDX : MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) – marketscreener.com

The following discussion and analysis of our financial condition and results ofoperations should be read together with the unaudited condensed consolidatedfinancial statements and related notes included elsewhere in Item 1 of Part I ofthis Quarterly Report on Form 10-Q and with the audited consolidated financialstatements and the related notes included in our Annual Report on Form 10-K forthe fiscal year ended December 31, 2019, filed with the Securities and ExchangeCommission, or the SEC, on February 28, 2020.SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSThis Quarterly Report on Form 10-Q contains forward-looking statements withinthe meaning of Section 27A of the Securities Act of 1933, as amended, andSection 21E of the Securities Exchange Act of 1934, as amended. All statementscontained in this Quarterly Report on Form 10-Q other than statements ofhistorical fact, including statements regarding our future results of operationsand financial position, our business strategy and plans, and our objectives forfuture operations, are forward-looking statements. The words “believe,” “may,””will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,””should,” “would,” “project,” “plan,” “target,” “contemplate,” “predict,””expect” and the negative and plural forms of these words and similarexpressions are intended to identify forward-looking statements.These forward-looking statements may include, but are not limited to, statementsconcerning the following:the potential impact to our business, revenue, financial condition andemployees, including disruptions to our testing services, laboratories, clinicaltrials, supply chain and operations, due to the COVID-19 global pandemic;our ability to take advantage of opportunities under the Coronavirus Aid,Relief, and Economic Security Act, or the CARES Act, and the potential impact ofthe CARES Act on our business, results of operations, financial condition orliquidity;our ability to generate revenue and increase the commercial success of ourcurrent and future testing services, products and digital solutions;our ability to obtain, maintain and expand reimbursement coverage from payersfor our current and other future testing services, if any;our plans and ability to continue updating our testing services, products anddigital solutions to maintain our leading position in transplantations;the outcome or success of our clinical trial collaborations and registrystudies; including Kidney Allograft Outcomes AlloSure Registry, or K-OAR, theOutcomes of KidneyCare on Renal Allografts registry study, or OKRA, and theSurveillance HeartCare Outcomes Registry, or SHORE;the favorable review of our testing services and product offerings, and ourfuture solutions, if any, in peer-reviewed publications;our ability to obtain additional financing on terms favorable to us, or at all;our anticipated cash needs and our anticipated uses of our funds, including ourestimates regarding operating expenses and capital requirements;anticipated trends and challenges in our business and the markets in which weoperate;our dependence on certain of our suppliers, service providers and otherdistribution partners; 25——————————————————————————– Table of Contentsdisruptions to our business, including disruptions at our laboratories andmanufacturing facilities;our ability to retain key members of our management team;our ability to make successful acquisitions or investments and to manage theintegration of such acquisitions or investments;our ability to expand internationally;our compliance with federal, state and foreign regulatory requirements;our ability to protect and enforce our intellectual property rights, ourstrategies regarding filing additional patent applications to strengthen ourintellectual property rights, and our ability to defend against intellectualproperty claims that may be brought against us;our ability to successfully assert, defend against or settle any litigationbrought by or against us or other legal matters or disputes; andour ability to comply with the requirements of being a public company.These forward-looking statements are subject to a number of risks, uncertaintiesand assumptions, including those described in the section entitled “RiskFactors” in this Quarterly Report on Form 10-Q and in our Annual Report on Form10-K for the fiscal year ended December 31, 2019, filed with the SEC onFebruary 28, 2020. Moreover, we operate in a very competitive and rapidlychanging environment, and new risks emerge from time to time. It is not possiblefor our management to predict all risks, nor can we assess the impact of allfactors on our business or the extent to which any factor, or combination offactors, may cause actual results to differ materially and adversely from thosecontained in any forward-looking statements we may make. In light of theserisks, uncertainties and assumptions, the forward-looking events andcircumstances discussed in this report may not occur and actual results coulddiffer materially and adversely from those anticipated or implied in theforward-looking statements.You should not rely upon forward-looking statements as predictions of futureevents. Although we believe that the expectations reflected in theforward-looking statements are reasonable, we cannot guarantee that the futureresults, levels of activity, performance or events and circumstances reflectedin the forward-looking statements will be achieved or occur. Moreover, neitherwe nor any other person assumes responsibility for the accuracy and completenessof the forward-looking statements. Except as required by law, we undertake noobligation to update publicly any forward-looking statements for any reasonafter the date of this report to conform these statements to actual results orto changes in our expectations.You should read this Quarterly Report on Form 10-Q and the documents that wereference in this Quarterly Report on Form 10-Q and have filed with the SEC asexhibits to this Quarterly Report on Form 10-Q with the understanding that ouractual future results, levels of activity, performance and events andcircumstances may be materially different from what we expect. We qualify allforward-looking statements by these cautionary statements.Overview and Recent HighlightsCareDx, Inc. (collectively, the “Company”, “we”, “us” and “our”) is a leadingprecision medicine company focused on the discovery, development andcommercialization of clinically differentiated, high-value diagnostic solutionsfor transplant patients and caregivers. We offer testing services, products, anddigital healthcare solutions along the pre- and post-transplant patient journey,and we are a leading provider of genomics-based information for transplantpatients.Highlights for the Three Months Ended June 30, 2020 and Recent HighlightsAchieved total revenue of $41.8 million for the three months ended June 30,2020, increasing 33% year-over-yearProvided over 17,100 AlloSure Kidney and AlloMap Heart patient results, withover 40% originating from RemoTraC and mobile phlebotomyRecorded first-ever AlloCell revenue from a cell therapy partnershipCompleted successful public offering raising $134.6 million in net proceeds,increasing cash and cash equivalents to approximately $211.4 millionTesting ServicesHeart 26——————————————————————————– Table of ContentsAlloMap Heart is a gene expression test that helps clinicians monitor andidentify heart transplant recipients with stable graft function who have a lowprobability of moderate-to-severe acute cellular rejection. Since 2008, we havesought to expand the adoption and utilization of our AlloMap Heart solutionthrough ongoing studies to substantiate the clinical utility and actionability,secure positive reimbursement decisions from large private and public payers,develop and enhance our relationships with key members of the transplantcommunity, including opinion leaders at major transplant centers, and exploreopportunities and technologies for the development of additional solutions forpost-transplant surveillance.We believe the use of AlloMap Heart, in conjunction with other clinicalindicators, can help healthcare providers and their patients better managelong-term care following a heart transplant, can improve patient care by helpinghealthcare providers avoid the use of unnecessary, invasive surveillancebiopsies and may help to determine the appropriate dosage levels ofimmunosuppressants. In 2008, AlloMap Heart received 510(k) clearance from theU.S. Food and Drug Administration for marketing and sale as a test to aid in theidentification of heart transplant recipients, who have a low probability ofmoderate/severe acute cellular rejection at the time of testing, in conjunctionwith standard clinical assessment.AlloMap Heart has been a covered service for Medicare beneficiaries sinceJanuary 1, 2006. The Medicare reimbursement rate for AlloMap Heart is currently$3,240. AlloMap Heart has also received positive coverage decisions forreimbursement from many of the largest U.S. private payers, including Aetna,Anthem, Cigna, Health Care Services Corporation, or HCSC, Humana, KaiserFoundation Health Plan, Inc. and UnitedHealthcare.We have also successfully completed a number of landmark clinical trials in thetransplant field demonstrating the clinical utility of AlloMap Heart forsurveillance of heart transplant recipients. We initially established theanalytical and clinical validity of AlloMap Heart on the basis of our CardiacAllograft Rejection Gene Expression Observational (Deng, M. et al., Am JTransplantation 2006), or CARGO, study, which was published in the AmericanJournal of Transplantation. A subsequent clinical utility trial, InvasiveMonitoring Attenuation through Gene Expression (Pham MX et al., N. Eng. J. Med.,2010), or IMAGE, published in The New England Journal of Medicine, demonstratedthat clinical outcomes in recipients managed with AlloMap Heart surveillancewere equivalent (non-inferior) to outcomes in recipients managed withbiopsies. The results of our clinical trials have also been presented at majormedical society congresses. AlloMap Heart is now recommended as part of theInternational Society for Heart and Lung Transplantation, or ISHLT, guidelines.HeartCareHeartCare includes the gene expression profiling technology of AlloMap Heartwith the dd-cfDNA analysis of AlloSure Heart in one surveillance solution. Anapproach to surveillance using HeartCare provides information from twocomplementary measures: (i) AlloMap Heart – a measure of immune activation, and(ii) AlloSure Heart – a measure of graft injury.Clinical validation data from the Donor-Derived Cell-Free DNA-Outcomes AlloMapRegistry (NCT02178943), or D-OAR, was published in American Journal ofTransplant, or AJT, in 2019. D-OAR was an observational, prospective,multicenter study to characterize the AlloSure-Heart dd-cfDNA in a routine,clinical surveillance setting with heart transplant recipients. The D-OAR studywas designed to validate that plasma levels of AlloSure-Heart dd-cfDNA candiscriminate acute rejection from no rejection, as determined by endomyocardialbiopsy criteria.HeartCare provides robust information about distinct biological processes, suchas immune quiescence, active injury, Acute Cellular Rejection, or ACR, andAntibody Mediated Rejection. In September 2018, we initiated the SHORE study.SHORE is a prospective, multi-center, observational, registry of patientsreceiving HeartCare for surveillance. Patients enrolled in SHORE will befollowed for 5 years with collection of clinical data and assessment of 5-yearoutcomes.In August 2019, AlloSure Heart received a positive draft Local CoverageDetermination for Medicare coverage. We have not yet made any applications toprivate payers for reimbursement coverage of AlloSure Heart.KidneyAlloSure Kidney, our transplant surveillance solution, which was commerciallylaunched in October 2017, is our donor-derived cell-free DNA, or dd-cfDNA,offering built on a Next Generation Sequencing, or NGS, platform. Intransplantation, 109 papers from 55 studies globally have shown the value ofdd-cfDNA in the management of solid organ transplantation. AlloSure allowssequencing of DNA and RNA much more quickly than the previously used Sangersequencing. AlloSure is able to discriminate dd-cfDNA from recipient-cell-freeDNA, targeting polymorphisms between donor and recipient. This single-nucleotidepolymorphism, or SNPs, approach across all the somatic chromosomes isspecifically designed for transplantation, allowing a scalable, high-qualitytest to differentiate dd-cfDNA.AlloSure Kidney has received positive coverage decisions for reimbursement fromMedicare. The Medicare reimbursement rate for AlloSure Kidney is $2,841.AlloSure Kidney has also received positive coverage decisions from BCBS SouthCarolina and BCBS Kansas City, and is reimbursed by other private payers on acase-by-case basis. 27——————————————————————————– Table of ContentsMultiple studies have demonstrated that significant allograft injury can occurin the absence of changes in serum creatinine. Thus, clinicians have limitedability to detect injury early and intervene to prevent long term damage usingthis marker. While histologic analysis of the allograft biopsy specimen remainsthe standard method used to assess injury and differentiate rejection from otherinjury in kidney transplants, as an invasive test with complications, repetitivebiopsies are not well tolerated. AlloSure provides a non-invasive test,assessing allograft injury that enables more frequent, quantitative and saferassessment of allograft rejection and injury status. Beyond allograft rejection,the assessment of molecular inflammation has shown further utility in theassessment of proteinuria, formation of De Novo donor specific antibodies, orDSAs, and also as a surrogate predictive measure of estimated glomerularfiltration rate, or eGFR, decline. Monitoring of graft injury through AlloSureallows clinicians to optimize allograft biopsies, identify allograft injury andguide immunosuppression management more accurately.Since the analytical validation paper in the Journal of Molecular Diagnostics in2016 before the commercial launch of AlloSure Kidney, an increasing body ofevidence supports the use of AlloSure dd-cfDNA in the assessment andsurveillance of kidney transplants. Bloom et al evaluated 102 kidney recipientsand demonstrated that dd-cfDNA levels could discriminate accurately andnon-invasively distinguish rejection from other types of graft injury. Incontrast, serum creatinine has area under the curve, or AUC, of 50%, showing nosignificant difference between patients with and without rejection. Multiplepublications and abstracts have shown AlloSure’s value in the management of BKviremia, as well as numerous pathologies that cause molecular inflammation andinjury such as DSAs and eGFR decline. Most recently its utility in theassessment of T-cell mediated rejection (TCMR) 1A and borderline rejection hasalso been published in the AJT.The prospective multicenter trial: Kidney Allograft Outcomes AlloSure KidneyRegistry, or the K-OAR study, is currently ongoing and has enrolled over 1,600patients, with plans to survey patients with AlloSure for 3 years and providefurther clinical utility of AlloSure Kidney in the surveillance of kidneytransplant recipients.KidneyCareKidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the geneexpression profiling technology of AlloMap Kidney and the predictive artificialintelligence technology of KidneyCare iBox in one surveillance solution. We havenot yet made any applications to payers for reimbursement coverage of AlloMapKidney or KidneyCare iBox.In September 2019, we announced the enrollment of the first patient in the OKRAstudy, which is an extension of the K-OAR study. OKRA is a prospective,multi-center, observational registry of patients receiving KidneyCare forsurveillance. Combined with K-OAR, 4,000 patients will be enrolled into thestudy.LungIn February 2019, AlloSure Lung became available for lung transplant patientsthrough a compassionate use program while the test is undergoing furtherstudies. AlloSure Lung applies proprietary NGS technology to measure dd-cfDNAfrom the donor lung in the recipient bloodstream to monitor graft injury. Wehave not yet made any applications to payers for reimbursement coverage ofAlloSure Lung.Cellular TherapyIn April 2020, we initiated a research partnership for AlloCell, a surveillancesolution that monitors the level of engraftment and persistence of allogeneiccells for patients who have received cell therapy transplants. AlloCell willinitially be commercialized through collaborative research agreements withbiopharma companies developing cell therapies.ProductsWe develop, manufacture, market and sell products that increase the chance ofsuccessful transplants by facilitating a better match between a solid organ orstem cell donor and a recipient, and help to provide post-transplantsurveillance of these recipients.QTYPE enables Human Leukocyte Antigen or HLA typing at a low to intermediateresolution for samples that require a fast turn-around-time and uses real-timepolymerase chain reaction, or PCR, methodology. Olerup SSP is used to type HLAalleles based on the sequence specific primer, or SSP, technology. Olerup SBT isa complete product range for sequence-based typing of HLA alleles.On May 4, 2018, we entered into a license agreement with Illumina, Inc., or theIllumina Agreement, which provides us with worldwide distribution, developmentand commercialization rights to Illumina’s NGS products and technologies for usein transplantation diagnostic testing.On June 1, 2018, we became the exclusive worldwide distributor of Illumina’sTruSight HLA product line. TruSight HLA is a high-resolution solution that usesNGS methodology. In addition, we were granted the exclusive right to develop andcommercialize other NGS product lines in the field of bone marrow and solidorgan transplantation on diagnostic testing. These 28——————————————————————————– Table of ContentsNGS products include: AlloSeq Tx, a high-resolution HLA typing solution, AlloSeqcfDNA, our surveillance solution designed to measure dd-cfDNA in blood to detectactive rejection in transplant recipients, and AlloSeq HCT, a NGS solution forchimerism testing for stem cell transplant recipients.In September 2019, we commercially launched AlloSeq cfDNA, our surveillancesolution designed to measure dd-cfDNA in blood to detect active rejection intransplant recipients, and we received CE mark approval on January 10, 2020. Ourability to increase the clinical uptake for AlloSeq cfDNA will be a result ofmultiple factors including local clinical education, customer lab technicalproficiency and levels of country-specific reimbursement.Also in September 2019, we commercially launched AlloSeq Tx, the first of itskind NGS high-resolution HLA typing solution utilizing hybrid capturetechnology. This technology enables the most comprehensive sequencing, coveringmore of the HLA genes than current solutions and adding coverage of non-HLAgenes that may impact transplant patient matching and management. AlloSeq Tx hassimple NGS workflow, with a single tube for processing and steps to reduceerrors. AlloSeq Tx 17 received CE mark approval on May 15, 2020.In June 2020, we commercially launched AlloSeq HCT, a NGS solution for chimerismtesting for stem cell transplant recipients. This technology can provide bettersensitivity and data analysis compared to current solutions on the market.DigitalIn 2019, we began providing digital solutions to transplant centers followingthe acquisition of Ottr Complete Transplant Management, or OttrCare, andXynManagement, Inc., or XynManagement.On May 7, 2019, we acquired 100% of the outstanding common stock of OttrCare.OttrCare was formed in 1993 and is a leading provider of transplant patienttracking software, or the Ottr software, which provides comprehensive solutionsfor transplant patient management. The Ottr software enables integration withelectronic medical records, systems, including Cerner and Epic, providingpatient surveillance management tools and outcomes data to transplant centers.On August 26, 2019, we acquired 100% of the outstanding common stock ofXynManagement. XynManagement provides two unique solutions, XynQAPI software, orXynQAPI, and Waitlist Management. XynQAPI simplifies transplant quality trackingand Scientific Registry of Transplant Recipients, or SRTR, reporting. WaitlistManagement includes a team of transplant assistants who maintain regular contactwith patients on the waitlist to help prepare for their transplant and maintaineligibility.COVID-19 ImpactIn the final weeks of March and during April 2020, with hospitals increasinglycaring for COVID-19 patients, hospital administrators chose to limit or evendefer, non-emergency procedures. Immunosuppressed transplant patients eitherself-prescribed or were asked to avoid transplant centers and caregiver visitsto reduce the risk of contracting COVID-19. As a result, with transplantsurveillance visits down, we experienced a slowdown in testing services volumesin the final weeks of March and during April 2020. As a response to the COVID-19pandemic, and to enable immune-compromised transplant patients to continue tohave their blood drawn, in late March 2020 we launched RemoTraC, a remotehome-based blood draw solution using mobile phlebotomy for AlloSure and AlloMapsurveillance tests, as well as for other standard monitoring tests. To date,more than 150 transplant centers can offer RemoTraC to their patients and over4,000 kidney, heart, and lung transplant patients have enrolled. Based onexisting and new relationships with partners, we have established a nationwidenetwork of more than 10,000 mobile phlebotomists. Following the introduction ofRemoTraC and with the easing of stay-at-home restrictions and the opening up ofmany hospitals to non-COVID-19 patients, our testing services volumes returnedto levels consistent with those experienced immediately prior to the impact ofCOVID-19, and volumes continued to be at or above those levels throughout May2020 and June 2020. However, our product business experienced a reduction inforecasted sales volume throughout the second quarter 2020, as we were unable toundertake onsite discussions and demonstrations of our recently launched NGSproducts, including AlloSeq Tx 17, which was awarded CE mark approval in May2020.We are maintaining our testing, manufacturing, and distribution facilities whileimplementing specific protocols to reduce contact among our employees. In areaswhere COVID-19 impacts healthcare operations, our field-based sales and clinicalsupport teams are supporting providers through telephone and online platforms.To reduce the risk to employees and their families from potential exposure toCOVID-19, most of our corporate employees have been asked to work from home. Wehave also restricted non-essential business travel to protect the health andsafety of its employees, patients, and customers. In addition, we have created aCOVID-19 task force that is responsible for crisis decision making, employeecommunications, enforcing pre-arrival temperature checking, daily healthcheck-ins and enhanced safety training/protocols in our offices for employeesthat cannot work from home.Due to COVID-19, quarantines, shelter-in-place and similar government orders, orthe perception that such orders, shutdowns or other restrictions on the conductof business operations could occur or could impact personnel at third-partysuppliers in the United States and other countries, or the availability or costof materials, there may be disruptions in our supply chain. Any 29——————————————————————————– Table of Contentsmanufacturing supply interruption of materials could adversely affect ourability to conduct ongoing and future research and testing activities.In addition, our clinical studies may be affected by the COVID-19 pandemic.Clinical site initiation and patient enrollment may be delayed due toprioritization of hospital resources toward the COVID-19 pandemic. Some patientsmay not be able to comply with clinical study protocols if quarantines impedepatient movement or interrupt healthcare services. Similarly, the ability torecruit and retain patients and principal investigators and site staff who, ashealthcare providers, may have heightened exposure to COVID-19, may adverselyimpact our clinical trial operations.Financial Operations OverviewRevenueWe derive our revenue from testing services, products sales and digital andother revenues. Revenue is recorded considering a five-step revenue recognitionmodel that includes identifying the contract with a customer, identifying theperformance obligations in the contract, determining the transaction price,allocating the transaction price to the performance obligations and recognizingrevenue when, or as, an entity satisfies a performance obligation.Testing Services RevenueOur testing services revenue is derived from AlloSure Kidney and AlloMap Hearttests, which represented 87% and 84% of our total revenues for the three and sixmonths ended June 30, 2020, respectively, and 82% of our total revenues for eachof the three and six months ended June 30, 2019. Our testing services revenuedepends on a number of factors, including (i) the number of tests performed;(ii) establishment of coverage policies by third-party insurers and governmentpayers; (iii) our ability to collect from payers with whom we do not havepositive coverage determination, which often requires that we pursue acase-by-case appeals process; (iv) our ability to recognize revenues on testsbilled prior to the establishment of reimbursement policies, contracts orpayment histories; (v) our ability to expand into markets outside of the UnitedStates; and (vi) how quickly we can successfully commercialize new productofferings.We currently market testing services to healthcare providers through our directsales force that targets transplant centers and their physicians, coordinatorsand nurse practitioners. The healthcare providers that order the tests and onwhose behalf we provide our testing services are generally not responsible forthe payment of these services. Amounts received by us vary from payer to payerbased on each payer’s internal coverage practices and policies. We generallybill third-party payers upon delivery of a test result report to the orderingphysician. As such, we take the assignment of benefits and the risk ofcollection from the third-party payer and individual patients.In April 2020, we announced our first biopharma research partnership forAlloCell, a surveillance solution that monitors the level of engraftment andpersistence of allogeneic cells for patients who have received cell therapytransplants. AlloCell will initially be commercialized through collaborativeresearch agreements with biopharma companies developing cell therapies.Product RevenueOur product revenue is derived primarily from sales of Olerup SSP, QTYPE,TruSight and AlloSeq Tx products. Product revenue represented 8% and 10% oftotal revenue for the three and six months ended June 30, 2020, respectively,and 15% and 16% of total revenue for the three and six months ended June 30,2019, respectively. We recognize product revenue from the sale of products toend-users, distributors and strategic partners when all revenue recognitioncriteria are satisfied. We generally have a contract or a purchase order from acustomer with the specified required terms of order, including the number ofproducts ordered. Transaction prices are determinable and products are deliveredand risk of loss passed to the customer upon either shipping or delivery, as perthe terms of the agreement. There are no further performance obligations relatedto a contract and revenue is recognized at the point of delivery consistent withthe terms of the contract or purchase order.Digital and Other RevenueOur digital and other revenue is mainly derived from sales of our Ottr softwareand XynQAPI licenses and services and other licensing agreements. Digital andother revenue represented 5% and 6% of total revenue for the three and sixmonths ended June 30, 2020, respectively, and 4% and 2% of total revenue for thethree and six months ended June 30, 2019, respectively.Critical Accounting Policies and Significant Judgments and EstimatesOur management’s discussion and analysis of our financial condition and resultsof operations is based on our unaudited condensed consolidated financialstatements, which have been prepared in accordance with United States generallyaccepted accounting principles. The preparation of these unaudited condensedconsolidated financial statements requires us to make estimates and assumptionsthat affect the reported amounts of assets and liabilities and the disclosure ofcontingent assets and liabilities at the date of the unaudited condensedconsolidated financial statements, as well as the reported revenue generated 30——————————————————————————– Table of Contentsand expenses incurred during the reporting periods. Our estimates are based onour historical experience and on various other factors that we believe arereasonable under the circumstances, the results of which form the basis formaking judgments about the carrying value of assets and liabilities that are notreadily apparent from other sources. Actual results may differ from theseestimates under different assumptions or conditions.We believe that the following critical accounting policies reflect the moresignificant estimates and assumptions used in the preparation of our financialstatements. We believe the following critical accounting policies are affectedby significant judgments and estimates used in the preparation of our unauditedcondensed consolidated financial statements:Revenue recognition;Business combination;Acquired intangible assets;Impairment of goodwill, intangible assets and other long-lived assets; andCommon stock warrant liability.There were no material changes in the matters for which we make criticalaccounting estimates in the preparation of our unaudited condensed consolidatedfinancial statements during the three and six months ended June 30, 2020 ascompared to those disclosed in Management’s Discussion and Analysis of FinancialCondition and Results of Operations included in our annual report on Form 10-Kfor the year ended December 31, 2019, except that there is no derivativeliability outstanding as of December 31, 2019 and June 30, 2020 and thedetermination of the estimated present value of lease payments using ourincremental borrowing rate as discussed in Note 2, Summary of SignificantAccounting Policies, in the unaudited condensed consolidated financialstatements included elsewhere in this Quarterly Report on Form 10-Q.Recently Issued Accounting StandardsRefer to Note 2, Summary of Significant Accounting Policies – Recent AccountingPronouncements, to the unaudited condensed consolidated financial statementsincluded elsewhere in this Quarterly Report on Form 10-Q for a description ofrecently issued accounting pronouncements, including the expected dates ofadoption and estimated effects on our results of operations, financial positionand cash flows. 31——————————————————————————– Table of ContentsResults of OperationsComparison of the Three Months Ended June 30, 2020 and 2019(In thousands) Three Months Ended June 30, 2020 2019 ChangeRevenue:Testing services revenue $ 36,293$ 25,677$ 10,616Product revenue 3,291 4,593 (1,302)Digital and other revenue 2,217 1,184 1,033Total revenue 41,801 31,454 10,347Cost of revenue 15,025 11,512 3,513Gross profit 26,776 19,942 6,834Operating expenses:Research and development 13,129 7,630 5,499Sales and marketing 12,134 10,644 1,490General and administrative 12,316 8,512 3,804Total operating expenses 37,579 26,786 10,793Loss from operations (10,803) (6,844) (3,959)Other income (expense):Interest income, net 21 300 (279)

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