StemCell Therapy

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (OTC:VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro BioPharma(303) 999-2130 Ext. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

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Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Benzinga

Newswise When smartphones and social media became ubiquitous for students, cyberbullying rates went up. This makes sense, of course, because there was now an almost limitless number of potential targets and aggressors, said Sameer Hinduja, Ph.D., a professor in the School of Criminology and Criminal Justice within FAUs College for Design and Social Inquiry, and co-director of the Cyberbullying Research Center. Well, during this unprecedented time when theyre all stuck at home, those same students will be using apps even more than they already do with them being forced to use online platforms for learning, regardless of their level of comfort or proficiency. Teachers are delivering education not just in learning management systems like Canvas, Blackboard, and Moodle, but even on Roblox, Twitch, and YouTube, among others.

In the midst of major crises where everyone is already on edge, Hinduja says hostility toward others tends to escalate along with self-preserving and self-defensive behaviors. This may manifest even more so between students in their online interactions their posts, comments, pictures and videos. Some of it will be mild, and some of it will be severe. Some of it will be what students are used to and will not bother them, but some of it will be brand new and a jarring, wounding experience. This may be especially true for those who are not used to learning and interacting in online-only spaces (and may also disproportionately affect more vulnerable populations of youth).

Hinduja cautions that many cyberbullying targets will hesitate to get help from their parents. When it happens, they may suffer silently since there will not be any visual cues for educators to see or investigate because the student is not physically at school. In addition, with everyone now receiving instruction online, students cannot readily stop by the guidance counselors office, chat with a teacher after class, or let their coach know about what is troubling them and affecting their ability to play sports (since youth sports also are shut down). Those opportunities for meaningful, connective conversations and check-ins largely will not happen organically.

Its also very possible that xenophobic/racist cyberbullying may go up. Some continue to call COVID-19 a foreign virus and parents have complained that their children are being accused as carriers just because they are Asian, said Hinduja. Im Asian and have dealt with my share of bullying based on race/ethnicity, and so I am particularly sensitive to this issue and simply do not want to see it spiral out of control.

Hinduja provides a number of suggestions for educators:

Students also are going to struggle with feelings of isolation because they are not able to go to school and connect and interact with their peers in person, said Hinduja.

He also suggests that parents need to be creative to make sure that their children do not suffer from extremes of social isolation:

With intentionality, graciousness, and good will, we dont have to just survive through this crisis. We can actually thrive, and our relationships with the youth we care for can be better off than they were before all of this even began, asserts Hinduja.

Additional information and tips can be found at the Cyberbullying Research Center.

- FAU -

About Florida Atlantic University: Florida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University, with an annual economic impact of $6.3 billion, serves more than 30,000 undergraduate and graduate students at sites throughout its six-county service region in southeast Florida. FAUs world-class teaching and research faculty serves students through 10 colleges: the Dorothy F. Schmidt College of Arts and Letters, the College of Business, the College for Design and Social Inquiry, the College of Education, the College of Engineering and Computer Science, the Graduate College, the Harriet L. Wilkes Honors College, the Charles E. Schmidt College of Medicine, the Christine E. Lynn College of Nursing and the Charles E. Schmidt College of Science. FAU is ranked as a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. The University is placing special focus on the rapid development of critical areas that form the basis of its strategic plan: Healthy aging, biotech, coastal and marine issues, neuroscience, regenerative medicine, informatics, lifespan and the environment. These areas provide opportunities for faculty and students to build upon FAUs existing strengths in research and scholarship. For more information, visit fau.edu.

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Another Unintended Consequence of COVID-19: Cyberbullying Could Increase - Newswise

With reliable and impactful research methodologies, Regenerative Medicine Market Research provides critical information pertaining to the growth of the global Regenerative Medicine market. Our team of analysts monitor the ongoing developments within the Regenerative Medicine space and provide an unbiased assessment of the global Regenerative Medicine market. The data included in the report are procured from reliable and trustworthy primary and secondary sources.

According to the findings of the report, the value of the global Regenerative Medicine market in 2018 was ~US$ XX (Mn/Bn) and expected to attain a value of ~US$ XX (Mn/Bn) by the end of 2029. In addition, the report reveals that the global Regenerative Medicine market is likely to grow at a CAGR of XX% during the forecast period (2019-2029).

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Regenerative Medicine Breakdown Data by TypeMono Avalanche AirbagsDual Avalanche AirbagsRegenerative Medicine Breakdown Data by ApplicationSkiingClimbingHikingOthers

Regenerative Medicine Production by RegionUnited StatesEuropeChinaJapanSouth KoreaIndiaOther Regions

Regenerative Medicine Consumption by RegionNorth AmericaUnited StatesCanadaMexicoAsia-PacificChinaIndiaJapanSouth KoreaAustraliaIndonesiaMalaysiaPhilippinesThailandVietnamEuropeGermanyFranceUKItalyRussiaRest of EuropeCentral & South AmericaBrazilRest of South AmericaMiddle East & AfricaGCC CountriesTurkeyEgyptSouth AfricaRest of Middle East & Africa

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Regenerative Medicine Market Report 2019: With Essential Analysis of Market, Industry News and Policies by Regions, Top Manufacturers, Types and...

Paul Bisaro and Gail Naughton, Ph.D., Appointed as Independent Directors

On behalf of the Board of Directors of TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading womens healthcare company, Chairman Tommy G. Thompson today announced the appointments of Paul Bisaro and Gail Naughton, Ph.D., to the Companys Board of Directors. The appointments fill two of the vacancies created by the resignations from the Board of Brian Bernick, M.D., John C.K. Milligan, IV and Nicholas Segal. Dr. Bernick will continue to serve as a Co-Founder of TherapeuticsMD on a full-time basis, supporting the Companys outreach with healthcare providers. Mr. Milligan will continue to serve as the President of TherapeuticsMD on a full-time basis, leading the Companys infrastructure and critical operations.

"We are very pleased to add Paul and Gail as the newest independent directors to our Board. Each has a wealth of experience as both directors and members of senior management at successful organizations," said former Governor and Secretary of Health and Human Services, Thompson. "This is an exciting time in our companys growth and development, and we believe that Paul and Gails respective skill sets will complement our recent transformation to a commercial organization."

"On behalf of the TherapeuticsMD Board of Directors, I would like to thank Brian, John and Nick for their service to our company," said Thompson. "Brians passion for innovation and persistence in solving patient needs are the reasons we have world-class products. Brian will continue to serve as our Co-Founder and play a key role in our outreach to healthcare providers. Johns commitment and can-do attitude built the infrastructure and critical operations that our Company has today. John will continue to serve as our President and lead our infrastructure and critical operations. Nick and his family were among our early investors and without their vision and commitment we would not be where we are today. We are excited to welcome Paul and Gail to the TherapeuticsMD Board of Directors. Each of them brings significant experience that we believe will activate our next stage of growth."

"I am very pleased and honored to be joining the TherapeuticsMD Board of Directors," said Mr. Bisaro. "I believe TherapeuticsMDs portfolio of differentiated products meets many of the significant unmet needs facing women today. In addition, I believe the Companys vitaCare platform which was created to remove the hassle and lack of visibility that patients often face when dealing with their insurance coverage, reimbursement and supply is a unique capability that supports TherapeuticsMDs patients. I look forward to working with the Board and management team to use these assets to help our patients while continuing to focus on creating long-term value for our shareholders."

Mr. Bisaro is an accomplished global business leader with more than 25 years of generic and branded pharmaceutical experience, and a track record of driving company growth through operational execution and corporate transformation. He has served as Executive Chairman of Allergan, plc (formerly Actavis, plc), President, Chief Executive Officer and a member of the Board of Directors of Actavis (and its predecessor firm Watson Pharmaceuticals, Inc.), Executive Chairman of Amneal Pharmaceuticals, Inc., and President, Chief Executive Officer and a member of the Board of Directors of Impax Laboratories, Inc. until its acquisition by Amneal. He also served as President, Chief Operating Officer and a member of the Board of Directors of Barr Pharmaceuticals, Inc.

"I am honored and delighted to be joining the Board of Directors of TherapeuticsMD. The directors and executives have created innovative products that are poised to greatly enhance womens health and I share in their vision in continuing to develop solutions that will be transformative to healthcare worldwide," said Dr. Naughton.

Dr. Naughton is an accomplished life sciences executive and researcher. Dr. Naughton founded two regenerative medicine companies and is the holder of more than 105 U.S. and foreign patents. She served as the Dean of the College of Business at San Diego State University from 2002-2011. Her current venture, Histogen, is focused on the development of novel solutions based on the products of cells grown under simulated embryonic conditions. She currently serves as Histogens Chief Scientific Officer and Chief Business Development Officer and is the inventor of its core technology. Dr. Naughton has brought several tissue engineered products to market including a product for severe burns (TransCyte), a dermal replacement for diabetic ulcers (Dermagraft), an aesthetic dermal filler (Cosmederm/Cosmeplast) and SkinMedicas TNS product for skin care. Dr. Naughton has been extensively published and is a frequent speaker in the field of tissue engineering and regenerative medicine. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering.

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"We are thankful to each of Brian, John and Nick for their years of service on our Board and look forward to continuing to work with Brian and John as key members of our leadership team," concluded TherapueticsMD Chief Executive Officer Robert G. Finizio. "As TherapeuticsMD looks to the future, adding two seasoned experts in Mr. Bisaro and Dr. Naughton to the Board while continuing to utilize two proven performers in Dr. Bernick and Mr. Milligan, is an ideal scenario."

About TherapeuticsMD

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The Company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit http://www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMDs objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of managements experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the companys control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the companys filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the companys ability to maintain or increase sales of its products; the companys ability to develop and commercialize IMVEXXY, ANNOVERA, BIJUVA and its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility, including the conditions to draw an additional tranche thereunder and whether the lender will make such tranche available; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the companys current or future approved products or preclude the approval of the companys future drug candidates; whether the FDA will approve the efficacy supplement for the lower dose of BIJUVA; the companys ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the companys reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the companys licensees to commercialize and distribute the companys products; the ability of the companys marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the companys products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the companys common stock and the concentration of power in its stock ownership. PDF copies of the companys historical press releases and financial tables can be viewed and downloaded at it website: http://www.therapeuticsmd.com/pressreleases.aspx.

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Contacts

Investor Contact Nichol OchsnerVice President, Investor Relations561-961-1900, ext. 2088Nochsner@TherapeuticsMD.com

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TherapeuticsMD Strengthens Board with Appointment of Industry Leaders - Yahoo Finance

The positioning of the Global Cell Culture Market vendors in FPNV Positioning Matrix are determined by Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) and placed into four quadrants (F: Forefront, P: Pathfinders, N: Niche, and V: Vital).

New York, March 25, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Cell Culture Market - Premium Insight, Competitive News Feed Analysis, Company Usability Profiles, Market Sizing & Forecasts to 2025" - https://www.reportlinker.com/p05872141/?utm_source=GNW

The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Culture Market including are Becton, Dickinson and Company, Cellgenix, Corning, Danaher, Eppendorf, Fujifilm Irvine Scientific, GE Healthcare, Hi-Media Laboratories, Invivogen, Lonza Group AG, Merck KGaA, Miltenyi Biotec, Promocell, and Sartorius AG.

On the basis of Product, the Global Cell Culture Market is studied across Consumables and Equipment.

On the basis of Application , the Global Cell Culture Market is studied across Biopharmaceutical Production, Diagnostics, Drug Screening and Development, Stem Cell Research, and Tissue Engineering & Regenerative Medicine.

On the basis of End User , the Global Cell Culture Market is studied across Cell Banks, Hospitals and Diagnostic Laboratories, Pharmaceutical & Biotechnology Companies, and Research Institutes.

For the detailed coverage of the study, the market has been geographically divided into the Americas, Asia-Pacific, and Europe, Middle East & Africa. The report provides details of qualitative and quantitative insights about the major countries in the region and taps the major regional developments in detail.

In the report, we have covered two proprietary models, the FPNV Positioning Matrix and Competitive Strategic Window. The FPNV Positioning Matrix analyses the competitive market place for the players in terms of product satisfaction and business strategy they adopt to sustain in the market. The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisitions strategies, geography expansion, research & development, new product introduction strategies to execute further business expansion and growth.

Research Methodology:Our market forecasting is based on a market model derived from market connectivity, dynamics, and identified influential factors around which assumptions about the market are made. These assumptions are enlightened by fact-bases, put by primary and secondary research instruments, regressive analysis and an extensive connect with industry people. Market forecasting derived from in-depth understanding attained from future market spending patterns provides quantified insight to support your decision-making process. The interview is recorded, and the information gathered in put on the drawing board with the information collected through secondary research.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on sulfuric acid offered by the key players in the Global Cell Culture Market 2. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments in the Global Cell Culture Market 3. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets for the Global Cell Culture Market 4. Market Diversification: Provides detailed information about new products launches, untapped geographies, recent developments, and investments in the Global Cell Culture Market 5. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players in the Global Cell Culture Market

The report answers questions such as:1. What is the market size of Cell Culture market in the Global?2. What are the factors that affect the growth in the Global Cell Culture Market over the forecast period?3. What is the competitive position in the Global Cell Culture Market?4. Which are the best product areas to be invested in over the forecast period in the Global Cell Culture Market?5. What are the opportunities in the Global Cell Culture Market?6. What are the modes of entering the Global Cell Culture Market?Read the full report: https://www.reportlinker.com/p05872141/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Cell Culture Market is expected to grow from USD 14,923.23 Million in 2018 to USD 35,236.23 Million by the end of 2025 at a Compound Annual...

Lake Forest Mar 27, 2020 (Thomson StreetEvents) -- Edited Transcript of CryoPort Inc earnings conference call or presentation Thursday, March 5, 2020 at 10:00:00pm GMT

* Jerrell W. Shelton

Cryoport, Inc. - Chairman, President & CEO

* Mark W. Sawicki

Cryoport, Inc. - Chief Commercial Officer

* Robert S. Stefanovich

Cryoport, Inc. - CFO, Treasurer & Corporate Secretary

B. Riley FBR, Inc., Research Division - Senior Analyst

Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst

SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst

Kanan, Corbin, Schupak & Aronow, Inc. - Managing Partner

Welcome to the Cryoport, Inc. Full Year 2019 Earnings Conference Call. (Operator Instructions) And the conference is being recorded. (Operator Instructions)

I would now like to turn the conference over to Todd Fromer, the Managing Partner, KCSA. Please go ahead.

Todd Fromer, Kanan, Corbin, Schupak & Aronow, Inc. - Managing Partner [2]

Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and not on information currently available to our management team. Our management team believes these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experiences and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A, Risk Factors and elsewhere in our annual report on Form 10-K filed with the Securities and Exchange Commission and those described from time to time in other reports, which we file with the Securities and Exchange Commission.

I would now like to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [3]

Thank you, Todd. Good afternoon, ladies and gentlemen. Thank you for joining us today. With me this afternoon is our Chief Financial Officer, Mr. Robert Stefanovich; and our Chief Commercial Officer, Dr. Mark Sawicki.

As a reminder, we've uploaded our 2019 Year in Review document to our website. It can be found in the Investor Relations section under Events & Presentations. This document provides a review of our recent financial and operational performance and a general business outlook. So if you have not had a chance to read it, I would encourage you to go to the website and download it.

As with previous quarters, on this conference call, we will provide you with a brief general update. And then we'll move to the question-and-answer session, where we will address your queries regarding our company's results.

Now for the update. We reported record revenues of $33.9 million for fiscal year 2019, an increase of 73% from fiscal year 2018. This strong result was driven partly by our commercial agreements supporting Gilead's YESCARTA and Novartis' KYMRIAH, which contributed $8.3 million in the 12-month period, an increase of 295% or $6.2 million compared with the prior year. Revenue from our commercial agreements is expected to continue to grow throughout 2020 and will include revenue from the commercial launch of bluebird bio's ZYNTEGLO, commencing during the first quarter of 2020.

A record total of 5 Cryoport-supported Marketing Authorization Applications and Biologics Licensing Applications were filed during the fourth quarter of 2019. We expect approximately 10 additional Cryoport-supported MAAs and BLAs to be filed in 2020 based on internal information and forecasts from the Alliance for Regenerative Medicine.

As the number of cell and gene therapies and clinical trials increased, we secured new clients and expanded our market share with the global regenerative medicine market. During our fourth quarter, we added a net total of 11 clinical trials, bringing the total number of regenerative therapy clinical trials supported by Cryoport to a record 436, of which 56 are currently in Phase III compared with 357 trials at the end of 2018, of which 47 were in Phase III.

During the year, to further advance our leadership position, we invested in enhancing our platform by entering the biostorage market with the acquisition of Cryogene and launching the first ever Cryoport Express Advanced Therapy Shipper product line, which guarantees each shipper has been used only for human use, is cleaned with 99.9999% effectiveness and provides complete traceability of all equipment, components and commodities. As a result of these investments last year, we're now providing our global clients with an expanded platform of critical solutions that include both highly differentiated temperature-controlled logistics and biostorage services.

With the regenerative medicine market growing rapidly, Cryoport is developing the network of partners, processes and systems that support a Compliance Unified Ecosystem within the life sciences industry. We have successfully secured several top-tier partnerships, including Lonza, Vineti, McKesson, EVERSANA and further integrating other solutions into the life sciences industry by providing scalable, standardized and compliant solutions focused on the supply chain of regenerative therapies.

In 2020, we are continuing to expand our global supply chain network and platform of advanced therapies for life sciences, including through the build-out of Global Supply Chain Centers in Morris Plains, New Jersey; and Houston, Texas. We believe that Cryoport's strong business model and balance sheet has us well positioned for both continued organic and acquisitive growth. Our market-leading position and superior technology platforms also give us the ability to scale our operations and to expand our support of the global regenerative medicine ecosystem as the market continues to demonstrate rapid and accelerating growth.

Now I'll turn the call over to the operator to open the telephone lines for your questions and our answers.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Brandon Couillard with Jefferies.

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Unidentified Analyst, [2]

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This is [Matt] on for Brandon. First one, if we look at the clinical trial revenues or the noncommercial biopharma revenues, essentially flat in the second half of the year versus the first half of the year, even though you added more than 20 new clinical trials in the -- versus the first half. Can you just help us reconcile the trend of your ongoing growth in supported clinical trials across the 3 phases? Is it simply timing issues as the trials transition and ramp from their various clinical phases? And then as a follow-up to that, are the ballpark revenue ranges or bands you have historically laid out by clinical trial phases still relevant today?

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Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [3]

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Yes. So there's not all of that in the answer, but I'm going to turn that over to Mark Sawicki to answer the question.

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Mark W. Sawicki, Cryoport, Inc. - Chief Commercial Officer [4]

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Yes, thanks. So the bottom line on clinical trial activity and associated revenue is that we use clinical trials as a pipeline for ultimately commercial revenue, which has by far a larger revenue basis associated with a given program and cycle. Clinical does, in its inherent nature, have more volatility. And volatility can be associated with interruptions in trials, holds between phases or terminations due to lack of progression, which obviously, we outlined in the earnings release.

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Unidentified Analyst, [5]

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And then on the biostorage side, you made some progress cross-selling to your existing customer base there and recently onboarded several clients to the Cryogene platform. Curious if you can just kind of provide any initial feedback, what it is about their offering that's resonating with your customers? And then anything you're penciling in for 2020 in terms of revenue synergies from Cryogene?

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Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [6]

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You want to take that, Mark?

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Mark W. Sawicki, Cryoport, Inc. - Chief Commercial Officer [7]

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Sure. So we're absolutely seeing crossover between the Cryoport and Cryogene businesses, which is one of the reasons we moved forward with the acquisition last year. And we do believe that, that will accelerate in this fiscal year. The primary driver behind that is folks moving towards an integrated or a single-supplier supply chain, so they want to not only be able to support the distribution aspects through our supply chain logistics platform, but also storage.

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Operator [8]

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The next question comes from Puneet Souda with SVB Leerink.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [9]

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So Jerry, first one for you and maybe

Mark can chime in into it too. Wanted to understand why commercial revenue was stepping down here when revenue for both the commercial therapies were up. Can you provide maybe how much of that was ASP driven? Or is there some other dynamic that we're unclear on? And just wanted to understand if -- how is that shaping up in the first quarter.

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Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [10]

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Yes. Yes, that is a good question, Puneet. The commercial revenues that we report are divided into 2 primary categories. One of these is patient and shipping-related revenues. And the second category is services, where, for example, our customers asked us for consulting or lane validations or custom secondary packaging or program management and that sort of thing. So in the fourth quarter, there was a bit of a drop from the third quarter revenue as a result of the nonshipping services-related revenue dropping.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [11]

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And would you expect that to recover again here in the first quarter? Or what's your expectation on that revenue? Or is that something we should expect to decline through the year?

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Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [12]

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It's a constant flow. It just had a drop in that last quarter. But it's -- there's constantly activity in these areas. There's always a need here.

This is evolving -- this is an evolving space. And so it's just -- it's going to continue to develop.

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Mark W. Sawicki, Cryoport, Inc. - Chief Commercial Officer [13]

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Yes. Puneet, it's -- as Jerry has said -- yes, the numbers will rebound.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [14]

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Sorry, I didn't catch that. Can you repeat?

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Mark W. Sawicki, Cryoport, Inc. - Chief Commercial Officer [15]

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I said -- yes, I said the numbers will rebound.

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Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [16]

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Mark said the same thing I said in a different way. He just simply said, the numbers will come back if we just had a drop for a quarter in those numbers.

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Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [17]

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Okay. All right. And then on clinical trials, I have a bigger question. I mean I appreciate there were 2 high-volume trials that were impacting the quarter. But wanted to get a view into what you're seeing so far in the year. Was that sort of onetime phenomena, one-off phenomena that you saw here? And I understand these are large clinical trials, but any sense that you're getting in 2020 so far on any other trials or a recovery in -- for Phase III trials?

Continued here:
Edited Transcript of CYRX earnings conference call or presentation 5-Mar-20 10:00pm GMT - Yahoo Finance

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Story continues

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro BioPharma(303) 999-2130 Ext. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/582759/Vitro-Biopharma-First-Quarter-ended-January-31-2020-Financial-Results-of-Operations

Originally posted here:
Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Yahoo Finance

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The Department of Biology at Hong Kong Baptist University (HKBU) has signed a collaboration agreement with Golden Meditech Holdings Limited (Golden Meditech). Under the terms of the agreement, the two partners will jointly conduct in-depth research in the area of cell therapy and will focus in particular on the treatment of neurodegenerative diseases using stem cell harvest technology developed at HKBU.

As part of the collaboration, Golden Meditech will contribute a sum of HK$15 million to HKBU in support of a contract research related to cell culture technology and cell therapies that can potentially treat neurodegenerative and other incurable diseases. This five-year in-depth research project will be conducted by a research team led by Professor Ken Yung Kin-lam from the Department of Biology at HKBU.

It is expected that the collaboration between HKBU and Golden Meditech will develop a new therapeutic approach to the treatment of neurodegenerative diseases. The results are expected to benefit patients not only in the Greater China Region but also the world.

Neurodegenerative diseases are mainly caused by the death or degeneration of nerve cells in the brain. According to statistics published in 2015, over 100 million people worldwide suffer from neurodegenerative diseases. As populations around the world continue to age, it is predicted that more than 20% of the global population (around 2 billion people) will be aged 60 or above by 2050. As a result, the number of patients suffering from neurodegenerative diseases will increase drastically and pose a threat to public health. At present, the drugs available to treat neurodegenerative diseases are not very effective and have many harmful side effects. Therefore, cell therapy is regarded as the most promising cure for such diseases.

The Department of Biology is committed to conducting cell therapy research for the treatment of neurodegenerative diseases. A series of internationally influential research has been published and in some cases successfully commercialized.

Golden Meditech is an integrated healthcare enterprise in mainland China. It has established dominant positions in the medical devices and hospital market in the healthcare industry.

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HKBU Collaborates with Golden Meditech to Conduct Cell Therapy Research - QS WOW News

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AlloVir, a late-clinical stage allogeneic T-cell immunotherapy company, today announced it has been granted Orphan Drug Designation from the European Medicines Agency (EMA) for Viralym-M (ALVR105) as a potential treatment of viral diseases and infections in patients undergoing hematopoietic stem cell transplantation (HSCT). Viralym-M is the companys lead allogeneic, off-the-shelf, multi-virus specific T-cell therapy, being developed for the treatment and prevention of serious viral diseases caused by six commonly occurring, devastating viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus, adenovirus, and JC virus. Viral diseases are a primary reason for poor outcomes in transplant patients, resulting in potentially devastating and life-threatening consequences.

In addition to Orphan Drug Designation, Viralym-M has been granted PRIority MEdicines (PRIME) designation from the EMA and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). Viralym-M is one of only seven investigational therapies, to date, to receive both PRIME and RMAT designations from the EMA and FDA, respectively. AlloVir plans to initiate Phase 3 pivotal and Phase 2 proof-of-concept studies with Viralym-M in 2020 targeting six commonly occurring, devastating and life-threatening viral pathogens.

At AlloVir, we are committed to advancing allogeneic, off-the-shelf novel T-cell therapies with the potential to improve the way we treat and prevent devastating viral diseases, said Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences of AlloVir. The Orphan Drug Designation by the EMA acknowledges the critical need for new treatment options for patients who have undergone stem cell transplant and are at risk of the serious consequences of viral diseases. Also, leveraging PRIME and RMAT designations, we are working to quickly advance Viralym-M through late-stage clinical development to bring, what we believe to be a transformative new therapy, to patients in the U.S., European Union and eventually around the world.

The EMA grants Orphan Drug Designation status for products intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, and where the product represents a significant benefit over existing treatments. Orphan Drug Designation provides companies with certain benefits and incentives in the EU, including a 10-year period of market exclusivity after product approval, reduced regulatory fees and protocol assistance.

About Opportunistic Viral Diseases

In healthy individuals, virus-specific T-cells from the bodys natural defense system provide protection against numerous disease-causing viruses. However, in patients with a weakened immune system these viruses may be uncontrolled. Viral diseases are common, with potentially devastating and life-threatening consequences in immunocompromised patients. For example, up to 90% of patients will reactivate at least one virus following an allogeneic HSCT and two-thirds of these patients reactivate more than one virus, resulting in significant and prolonged morbidity, hospitalization and premature death. Typically, when viruses infect immunocompromised patients, standard antiviral treatment does not address the underlying problem of a weakened immune system and therefore, many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death.

About Viralym-M (ALVR105)

AlloVirs lead product Viralym-M (ALVR105) is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy targeting six common viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. In a positive Phase 2 proof-of-concept study, published in the Journal of Clinical Oncology (Tzannou, JCO, 2017), greater than 90% of patients who failed conventional treatment and received Viralym-M, demonstrated a predefined criteria for a complete or partial clinical response, most with complete elimination of detectable virus in the blood and resolution of major clinical symptoms. The company plans to initiate pivotal and proof-of-concept studies with Viralym-M in 2020 for treatment and prevention of severe and life-threatening viral diseases.

Viralym-M has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) designation from European Medicines Agency (EMA).

About AlloVir

AlloVir, formerly ViraCyte, is an ElevateBio portfolio company that was founded in 2013 and is the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The companys technology platforms deliver commercially scalable solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viral pathogens for immunocompromised patients under viral attack. AlloVirs technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

AlloVirs investors include Fidelity Research and Management Company, Gilead Sciences, F2 Ventures, The Invus Group, Redmile Group, EcoR1, Samsara Biocapital, and Leerink Partners Co-investment Fund, LLC.

AlloVir is an ElevateBio portfolio company. More information can be found at http://www.allovir.com.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and transitional research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, Emerson Collective, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

See the original post:
European Medicines Agency Grants Orphan Drug Designation to AlloVir's Viralym-M, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy -...

So this is how it ends. Cancellations, social distancing, and the Great Toilet Paper Shortage. Dogs and cats living together, mass hysteria.

With no Madness to distract us from the madness, with mass media fanning the flames of freak-out and social media throwing gasoline on them, whats a Christian to do? Shall we hunker in those bunkers once built beneath basements for weathering nuclear winter, or scamper to their more recent manifestation, the panic room? Or worse, shall we proceed as if the gospel of Jesus Christ hasnt prepared us for just such a time as this?

The sanctity of life remains more relevant than ever in these moments. Heres how we can continue to proclaim it and put it into practice with courage and compassion while facing a deadly pestilence.

1. Please lets not cancel church services. Many early Christians assembled to rejoice in the greater graces of God under threat of arrest or death. Persecuted brothers and sisters in other parts of the world still do.

Of course, we sometimes suspend services due to inclement weather, but in those circumstances, we face far graver and more immediate danger. The risks the current sickness brings, even to particularly susceptible populations, only moderately exceed the everyday contagions to which we commonly expose each other.

Perhaps individuals feeling ill should excuse themselves, but even for them we ought not obligate absence from those divine promises and blessings without which humankind cannot live by bread alone. We can take other measures (washing hands, keeping physical distance, sanitizing surfaces). Maybe holding more services, rather than fewer, would reduce the attendance at each one and mitigate the germs spread.

Thankfully, Martin Luthers suddenly chic treatise about plague also encourages involvement in corporate worship (as do guidelines from my church body, the Lutheran Church-Missouri Synod). God delivers His gospel gifts as exactly the antidote for the anxieties we are presently experiencing. They inspire the very care and service for our neighbor that such situations require.

2. Lets not blame public officials or overseas populations. When the vector of the terror is person-to-person contact, we become suspicious of each other. Distances and differences can further impede goodwill.

When whole nations and regions get infected, and in a world that makes a god of government, we expect civic authorities and agencies to arrange salvation. Practice patience rather than complaining and commending instead of condemning. Were going to need one another to overcome both this peril and its opportunistic secondary infection: the rupture of relationships.

3. Lets celebrate community. What an unprecedented opportunity we have in extended school closings, travel restrictions, and working from home (or furloughs). This collective predicament has the potential to unite families, communities, and countries in ways that our atomic-paced and achievement-driven culture doesnt usually permit.

Lean in to the household. Play board games. Read stories aloud. Reach out to aging relatives. Catch up with old friends. Check in on isolated neighbors. Engage in an extended casual conversation with your husband or wife. How can we serve those whom the quarantining affects most adversely?

4. Reconsider the role of our bodies. The increased attention to disease transmission wonderfully confronts us some wonderful realities. Sexuality doesnt encompass ones entire identity. We cannot reduce a persons value to how attractive or productive we find her.

Comfort, luxury, and indulgence do not trump everything else. Theres no such thing as a personal choice or a private decision. We affect others even unintentionally wherever we go and whatever we do, for worse and for better. These bodies are gifts, not rights or burdens.

5. Lets not abandon the elderly. We can allocate health-care resources, even in crisis, according to urgency of needs and not duration of years. Quality-of-life is in the eye of the beholder, and such subjective assessments hardly make safe or fair means for managing matters when survivals at stake.

This plague already disproportionately endangers the aged. Sacrificing them to the beast will embolden, not appease it.

6. Lets not abort the unborn. Some will use this virus as the latest excuse to experiment with embryos for developing another vaccine or a stem-cell therapy. One knucklehead abortionist already advocated removing restrictions on RU-486 because the increased time at home will result in more surprise pregnancies.

Unless we amount to nothing more than hedonist animals (in which case weve much more than microbes to worry about), children represent our future and the reason we work, earn, and journey in the first place. Do we have to let emergency reduce our race to spare parts? Widespread dread provides the least rational and most hazardous justification for medically cannibalizing our young.

7. Resist the temptation to fill the extra time with screens. Infotainment (news), binge-watching movies and series, and scrolling social media may poison us more than this bodily malady.

No media delivers just the facts, or distractions. They sell products and philosophies, and scares and stories sell even more than sex. Seek truth rather than news, which often consists mostly of rumors and exaggerations. Rather than resorting to technology and toys, dive headlong into what your mind and heart really crave: human contact.

8. Behold how helplessly defenseless and dependent we are. But for the grace of God, we cannot preserve ourselves against the tiniest menaces.

Humankinds selfishness long ago upset the harmony our Almighty Maker baked into the universe, and we have not strayed from competing ever since. Microscopic organisms are following our lead and assault us rather than synergizing (cursed is the ground because of you, multiplying your pain in childbearing).

On our own, fertilization to final breath leaves us little and feeble like an embryo, impaired and compromised like a hospital patient. Since our heart beats, lungs breathe, and eyes keep blinking, how gently and relentlessly does the Heavenly Father sustain us!

9. Take comfort and take courage, because no one suffers alone. Our Lord Jesus Christ has borne our sicknesses and carried our sorrows. He knows weeping and bleeding.

The Son of God humbled Himself unto slavery like us and submitted to death that He might tread the sod of its shadowy valley beside us. His crucified forgiveness has emptied suffering of any payback or punishment to fill it with redemptive purposes. Now in His hand even our pain accomplishes outcomes that far surpass its costs.

10. Remember the hope of a new creation. Whatever this world deprives will be restored and transcended by the resurrection of the body to everlasting life in the heavenly kingdom. Pray not just to be spared from sickness but to be saved from sin.

Pray not only for ourselves but for our every neighbor. Pray, watch, and await with eager anticipation the day when God shall wipe away every tear from our eyes and there will be no more disease and no more death.

Lets demonstrate the best of humanity and make the coronavirus pandemic of 2020 the most life-affirming, gospel-motivated event of our age.

Pastor Michael Salemink is executive director of Lutherans For Life.

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10 Positive Ways To Celebrate Life In The Shadow Of Coronavirus - The Federalist

For the first time, scientists have reprogrammed cells from a 114-year-old woman into induced pluripotent stem cells (iPS cells), a move which they describe as a significant step toward understanding"the underlying mechanisms of extreme longevity and disease resistance."

iPS cells are adult cells that have been genetically reprogrammed into an embryonic stem cell-like state and are able to give rise to any of the specialized cell types of the body, whether its neurons, blood cells, or heart cells.

Until this new project, researchers werent even certain whether they could create viable iPS cellsfrom someone so elderly, let alone a supercentenarian. Now they have shown it's possible to effectively make these aged cells resemble young pluripotent cells, the researchers believe they might have made a step towards the reversal of cellular aging.

"We set out to answer a big question: Can you reprogram cells this old?" Evan Snyder, stem cell researcher at Sanford Burnham Prebys Medical Discovery Institute in California, said in a statement.

"Now we have shown it can be done, and we have a valuable tool for finding the genes and other factors that slow down the aging process."

Reporting in the journal Biochemical and Biophysical Research Communications, researchers harnessed iPS cells from the blood cells of a 114-year-old woman, a healthy 43-year-old person, and an 8-year-old child with a rare genetic condition characterized by the rapid aging in childhood. These iPS cells were then turned into mesenchymal stem cells, cells that help maintain and repair the body's structural tissues differentiating into bone, cartilage, muscle, or fat cells.

Remarkably, the cells produced from the supercentenarian transformed just as easily as the others. They also noted the supercentenarian-derived stem cells appeared to have reset their telomeres.

Telomeresarethe protective caps on the end of a chromosome. Since they shorten each time a cell copies itself, they also get shorter as we age and eventually stop functioning properly. Thispersistent shortening allows researchers to use telomeres as a kind of aging clock in every cell.Interestingly, the stem cells from the supercentenarian showed no indication of this aging. They had effectively reset the clock on the cells from114 years to zero.

To dive deeper into this discovery, the researchers hope to compare body cells derived from the healthy iPSCs and supercentenarian iPSCs. The researchers could also start to use the supercentenarian cells to understand why certain people have such long lives compared to others.

Why do supercentenarians age so slowly? We are now set to answer that question in a way no one has been able to before, said Snyder.

Read more from the original source:
Scientists Have 'Reset' The Cellular Age Of Cells Taken From A 114-Year-Old Woman - IFLScience

VANCOUVER, March 25, 2020 /PRNewswire/ --Precision Nanosystems, Inc. (PNI), a global leader in enabling transformative nanomedicinesannounced today that the companyentered into a license agreement with FUJIFILM Corporationto adopt PNI's NanoAssemblr technology and complete suite of instruments for Fujifilm'sstate-of-the-art manufacturing facility, compatible with GMP regulations of US, Europe and Japan.

As part of this agreement, Fujifilm has the rights to offer contract manufacturing services using PNI's proprietary technology andalso use PNI technology to develop and commercialize its internal therapeutic drug products. PNI and Fujifilm will work together to combine and democratize the scalable manufacturing of gene therapy and small-molecule based nanomedicines using Fujifilm's and PNI's proprietary technologies.

PNI's NanoAssemblr technology is powered by the disruptive NxGen microfluidics mixing technology designed exclusively for scalable nanomedicine development while maintaining precise control and reproducibility. The NanoAssemblr platform is comprised of the Spark, Ignite, Blaze and GMP Systems that together offer a flexible solution for accelerated, cost-effective development and scalable manufacture of high-quality gene therapy, small molecule and protein-based nanomedicine products.

James Taylor, Co-Founder and CEO of PNI said, "We are thrilled to work with Fujifilm to enable our technology in support of clinical clients as they progress their therapeutic programs from the laboratory to the clinic and commercial. Fujifilm's R&D teams will combinethe PNI platform andtheir proprietary Drug Delivery Systems technologies and we look forward to the seamless scaling up and manufacturing of innovative medicines to impact human well-being."

Nanomedicinesis one of the focus areas of Fujifilm, tapping into itsadvanced technologies such as nano-technology, process engineering technology and analysis technology. "We are excited to work with PNI to bring on board the NanoAssemblr suite of products and cutting-edge nanomedicines manufacturing technology," said Junji Okada, Senior Vice President, General Manager of Pharmaceutical products division, FUJIFILM Corporation. "Tapping into Fujifilm's state of the art technology, expertise and thefacility for the provision of pre-clinical and GMP manufacturing services, we are committed to creating innovative and high-value pharmaceutical productsnot only through internal development but also by providing high quality liposomal formulations to our partner companies."

About Precision NanoSystems Inc.

Precision NanoSystems Inc. (PNI) proprietary NanoAssemblr Platform enables the rapid, reproducible, and scalable manufacture of next generation nanoparticle formulations for the targeted delivery of therapeutic and diagnostic agents to cells and tissues in the body. PNI provides instruments, reagents and services to life sciences researchers, including pharmaceutical companies, and builds strategic collaborations to revolutionize healthcare through nanotechnology. For more information, visit http://www.precisionnanosystems.com.

About Fujifilm CorporationFUJIFILM Corporation, Tokyo, Japan is one of the major operating companies of FUJIFILM Holdings Corporation. The company brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2019, the company had global revenues of $22 billion, at an exchange rate of 111 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: http://www.fujifilmholdings.com.

Jane Alleva, Global Marketing Manager, Precision NanoSystems, Phone: 1 888 618 0031, ext 140, mobile 1 778 877 5473

SOURCE Precision Nanosystems

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Precision NanoSystems Announces Partnership with Fujifilm for the Development and GMP Manufacturing of Nanoparticle Based Therapeutics - Yahoo Finance

KANAZAWA, Japan, March 25, 2020 /PRNewswire/ -- In a recent study published in Autophagy, researchers at Kanazawa University show how abnormalities in a gene called TPR can lead to pediatric brain cancer.

Ependymoma is a rare form of brain cancer that implicates children and is often tricky to diagnose. Since effective treatment options can be initiated only after a well-formed diagnosis, there is a dire need among the medical community to identify markers for ependymoma, which in turn, will help oncologists tailor therapy better. Richard Wong's and Mitsutoshi Nakada's team at Kanazawa University has now shown how one gene closely linked to ependymoma can help with not just diagnosis, but also treatment options for the condition.

A gene known as TPR shows an elevated presence in 38% of ependymoma cases. Thus, the team first sought out to investigate how an increase in the TPR gene correlated to the development of cancer cells. Each gene present in a cell contains a code for the creation of a specific protein. The TPR gene contains the code for an eponymous protein. Therefore, cancer samples from patients were assessed for the levels of TPR protein. As expected, levels of TPR were abnormally high in these tumor tissues.

The researchers then moved on to investigate whether these abnormal TPR levels could lead to cancer progression. For this purpose, mice were implanted with human ependymoma cancer tissue into their brains. The TPR gene was then deleted in these tissues so that the mice were unable to create the TPR protein. When the tumor tissues were subsequently analyzed, a reduction of cancer growth was seen. The TPR gene was thus vital for the growth of ependymoma tumors.

Deletion of the TPR protein is known to induce a process called autophagy within cells. Autophagy is initiated when a cell is under undue stress and results in the death of damaged cells. The patient tumor samples, with their high levels of TPR protein, showed little or no presence of autophagy. However, autophagy was remarkably high in the mice with TPR depletion. Ependymoma cells were thus spared of autophagic death due to the increased presence of TPR. These damaged cells continued to grow by circumventing the biological systems set up to keep them in check. The high TPR levels were also accompanied by an increase in HSF-1 and MTOR, molecules which are responsible for cell growth and survival.

Finally, the possibility of lowering TPR levels therapeutically to control the cancer was assessed. The mice were given a drug called rapamycin, which inhibits MTOR. The treatment not only led to decreased TPR levels, but also shrank the tumor tissues within their brains.

"Thus, TPR can serve as a potential biomarker, and MTOR inhibition could be an effective therapeutic approach for ependymoma patients," conclude the researchers. While looking out for increased levels of TPR in patients can help oncologists achieve a more comprehensive diagnosis, reducing TPR levels with the help of drugs can help keep the tumors in check.

Background:

Autophagy: Autophagy, which literally translates to "self-eating" is the self-preservation mechanism of the body to get rid of damaged cells. Autophagy is initiated when an abnormal amount of proteins or toxins build up within a cell, which the cell cannot clear out. Conditions like Alzheimer's disease and Parkinson's disease arise when autophagic mechanisms within the cells start malfunctioning. Impaired autophagy is also known to be implicated in driving various forms of cancer.

Reference

Firli Rahmah Primula Dewi, Shabierjiang Jiapaer, Akiko Kobayashi, Masaharu Hazawa, Dini Kurnia Ikliptikawati, Hartono, Hemragul Sabit, Mitsutoshi Nakada, and Richard W. Wong. "Nucleoporin TPR (translocated promoter region, nuclear basket protein) upregulation alters MTOR-HSF1 trails and suppresses autophagy induction in ependymoma", Autophagy. Published online 24March2020.

DOI 10.1080/15548627.2020.1741318.

About Nano Life Science Institute (WPI-NanoLSI)

Home

Nano Life Science Institute (NanoLSI), Kanazawa University is a research center established in 2017 as part of the World Premier International Research Center Initiative of the Ministry of Education, Culture, Sports, Science and Technology. The objective of this initiative is to form world-tier research centers. NanoLSI combines the foremost knowledge of bio-scanning probe microscopy to establish 'nano-endoscopic techniques' to directly image, analyze, and manipulate biomolecules for insights into mechanisms governing life phenomena such as diseases.

About Kanazawa University

http://www.kanazawa-u.ac.jp/e/

As the leading comprehensive university on the Sea of Japan coast, Kanazawa University has contributed greatly to higher education and academic research in Japan since it was founded in 1949. The University has three colleges and 17 schools offering courses in subjects that include medicine, computer engineering, and humanities.

The University is located on the coast of the Sea of Japan in Kanazawa a city rich in history and culture. The city of Kanazawa has a highly respected intellectual profile since the time of the fiefdom (1598-1867). Kanazawa University is divided into two main campuses: Kakuma and Takaramachi for its approximately 10,200 students including 600 from overseas.

Further information

Hiroe Yoneda Vice Director of Public AffairsWPI Nano Life Science Institute (WPI-NanoLSI)Kanazawa UniversityKakuma-machi, Kanazawa 920-1192, JapanEmail: nanolsi-office@adm.kanazawa-u.ac.jp Tel: +81-(76)-234-4550

SOURCE Kanazawa University

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Kanazawa University Research: Insights into the Diagnosis and Treatment of Brain Cancer in Children - PR Newswire UK

Vir Biotechnology, a San Francisco-based biotechnology firm, said Wednesday that laboratory testing showed two of its antibody drugs appeared to neutralize the coronavirus that causes Covid-19 and that it would pursue testing them in people.

The company said that human tests of the drugs could begin in three to five months, putting it roughly in line with two other efforts to produce anti-coronavirus antibodies. Regeneron, based in Tarrytown, N.Y., has said that its antibodies could enter trials by early summer and that its treatment, if it proves effective, could be available for some uses in the fall. Eli Lilly, which is developing anti-SARS-CoV-2 antibodies with AbCellera, a Vancouver biotech, has said it hopes to begin human tests in four months.

Stopping this disease will take a combination of prevention and treatment approaches, Vir CEO George Scangos said in a statement. At Vir, we are fortunate that our existing antibody platform gave us a running start against COVID-19, and we have the internal and partnered capabilities to work on multiple approaches.

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Vir is working with the Cambridge, Mass., biotech firm Biogen, where Scangos was previously CEO, and Wuxi Biologics, a China-based manufacturing organization.

Antibodies are a part of the immune system that drug companies have learned to weaponize as treatments for diseases. An antibody drug against SARS-CoV-2 might either treat infection in very sick patients or prevent infection. It is one of many techniques researchers are attempting against Covid-19. For a rundown of approaches, see this story.

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Vir is taking a somewhat different approach from Regeneron. While Regeneron is going to choose two antibodies to use together, Vir has picked a single antibody. But Vir is modifying it in two different ways and testing the resulting two experimental drugs in parallel.

The first modification should make the antibodies last longer in the body, and is being done to both candidates. The second, in animal models, leads to long-term production of white blood cells that might lead to long-term immunity, as with a vaccine. If this proves effective, the antibody could be used to prevent infection.

Vir said it has also identified other antibodies that work differently, so that they might be combined with the two it is testing. And it is continuing to search for antibodies in the blood or patients who have survived SARS-CoV-2.

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Vir Biotechnology reports early progress in antibody treatment for Covid-19 - STAT

Dublin, March 24, 2020 (GLOBE NEWSWIRE) -- The "Agricultural Biotechnology: Emerging Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.

The study scope includes key agricultural biotechnology tools (i.e., next-generation DNA sequencing, biochips, RNA interference, synthetic biology tools, and gene editing tools); synthetic biology-enabled chemicals and biofuels; biotech seeds; and biologicals.

The report analyzes these technologies and products to determine present and future market sizes, and to forecast growth from 2019 through 2024. The report also discusses industry strategic alliances, industry structures, competitive dynamics, patent status and market driving forces.

The research provides in-depth coverage of the agricultural biotechnology industry structure, including genomics technology providers (e.g., genome editing, NGS and microarray companies); major seed companies; biotech trait companies; synthetic biology tools companies; companies developing plant feedstocks; and agricultural biologicals companies. It provides an in-depth analysis of major industry acquisitions and alliances during 2018 and 2019.

96 agricultural and biotechnology companies are profiled in this report.

The report includes:

Market Insights

Global megatrends are driving the need for higher agricultural yields, creating strong tailwinds for innovative seed traits and biological pesticides and stimulants.

World population growth, coupled with rising incomes, lead to consumption of higher-quality foods, including meat. This, in turn, creates higher consumption of feed crops, including maize, soy, and wheat. At the same time, the total acreage of arable land available for producing crops is under pressure from a range of forces, including growing populations, urbanization, and global warming.

These global forces are creating leverage in the industry to increase productivity and crop yields. Biotechnology provides strategic tools for the agricultural industry to meet these market demands. This report examines the role of these technologies in agriculture and quantifies their market impact.

Reasons for Doing the Study

Agriculture is a fundamental and strategic component of a country. As a result, agricultural technologies provide competitive geographic advantage and are highly desirable. Biotechnologies address the pressing industry need for higher crop yields and other desirable traits. Agricultural biotechnology is a key and growing component of the global agriculture industry and is thus of interest to a wide audience.

This report seeks to provide a qualitative and quantitative description of the agricultural biotechnology industry so that emerging market opportunities can be identified and exploited by the reader. The report does this by examining the main product applications and markets, thereby helping companies to prioritize product opportunities and strategic opportunities. The report highlights key market and industry trends, as well as quantifying the main market segments, in order to help the reader better understand industry structure and changes occurring in the industry.

Rapid changes in technology-intensive fields such as DNA sequencing, gene editing, and synthetic biology are driving new products and applications in agriculture. These developments create unique market opportunities. This report analyzes these trends and their impact on future markets for agricultural products.

Based on these market and technology dynamics, it is especially timely to examine the agricultural biotechnology industry.

Key Topics Covered

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Overview

Chapter 4 Technology Background

Chapter 5 Agricultural Biotechnology Applications

Chapter 6 DNA Read, Write and Edit Industries

Chapter 7 Acquisitions and Strategic Alliances

Chapter 8 Agricultural Biotechnology Markets

Chapter 9 Patents

Chapter 10 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/hib70i

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

CONTACT: ResearchAndMarkets.comLaura Wood, Senior Press Managerpress@researchandmarkets.comFor E.S.T Office Hours Call 1-917-300-0470For U.S./CAN Toll Free Call 1-800-526-8630For GMT Office Hours Call +353-1-416-8900

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Global Agricultural Biotechnology Markets, 2018-2024 - Discussion of the Opportunities in Biotechnology Tools, Genomic-Enabled Products and Biotech...

Board additions will enhance Companys ability to execute on key corporate initiatives

AUSTIN, Texas--(BUSINESS WIRE)--Genprex, Inc.. (Genprex or the Company) (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced the appointment of three new members to its Board of Directors. The new appointments are designed to strengthen the Company as it executes on its key clinical programs, continues to build its pipeline, and evaluates future license or corporate partnership agreements. The new Board members include Brent Longnecker, Chief Executive Officer of Longnecker & Associates, Jose A. Moreno Toscano, Chief Executive Officer of LFB USA Inc, and William R. (Will) Wilson, Jr., Chairman, President and Chief Executive Officer of Wilson Land & Cattle Co.

This strengthening of the Board of Directors closely follows the Company receiving Fast Track Designation from the Food and Drug Administration (FDA) for its lead drug candidate, raising more than $26 million from institutional investors over the last few months, and licensing a new gene therapy drug candidate for diabetes from the University of Pittsburgh. Also, just yesterday, the Company announced that it strengthened its management team by adding two new senior executives, Catherine Vaczy as Executive Vice President and Chief Strategy Officer, and Michael Redman as Executive Vice President and Chief Operating Officer.

We are honored to have Brent, Jose and Will join our Board in what we believe is a transformational time for our Company, said Rodney Varner, Chief Executive Officer of Genprex. Their combined experience in regulatory compliance, business development, clinical trial management, and deal structuring will be invaluable as we continue to our develop gene therapy drug candidates and pursue partnerships for our drug candidates. The addition of these outstanding directors, together with our new senior executive hires and a significantly strengthened balance sheet, puts us in an excellent position to execute our plans.

Brent Longnecker has more than 30 years of experience in corporate governance, executive compensation, and risk management consulting for public, private, and non-profit organizations. Mr. Longnecker built one of the countrys leading privately-held executive compensation and corporate governance consultancies, serving both domestic and international markets. Mr. Longnecker has deep expertise in healthcare, energy, real estate, manufacturing, and financial companies, regularly consulting with boards of directors, CEOs, key executives, and advisors in many major industries. He is a prolific author on the subjects of executive compensation and corporate governance.

Jose A. Moreno Toscano brings to the Company over 20 years of experience in the pharmaceutical and biotechnology industries, building, developing and transforming organizations. Mr. Moreno Toscano has a successful track record of identifying and capitalizing on opportunities to drive exponential revenue growth and market expansion, revitalizing underperforming operations and establishing foundations for successful start-up operations. His experience includes strategic planning, corporate restructuring, business development, M&A, investor relations, and general management.

William R. Wilson, Jr. has more than 40 years of experience as an attorney, with legal experience spanning health care regulation, biotechnology, clinical trial management, nursing home licensing and regulation, physician accreditation, securities, corporate governance, and contractual matters. He previously served as Judge of the 250th District Court of Travis County, Texas, where he presided over civil litigation, as well as Assistant District Attorney for Dallas County, Texas.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and other serious diseases. Genprexs technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and other serious diseases who currently have limited treatment options. Genprex works with world-class institutions and collaborators to in-license and develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches for patients with cancer and other serious diseases. The Companys lead product candidate, Oncoprex, is being evaluated as a treatment for non-small cell lung cancer (NSCLC). Oncoprex has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for Oncoprex immunogene therapy for NSCLC in combination therapy with osimertinib (AstraZenecas Tagrisso). For more information, please visit the Companys web site at http://www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprexs product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding our possible commercial partnerships and regarding our financial resources. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of Oncoprex, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including our gene therapy in diabetes, advance into clinical trials; our ability to enter into strategic partnerships and the success of those partnerships; the timing and success of obtaining FDA approval of Oncoprex and our other potential product candidates; and the extent and duration of the current and future economic challenges we may face. These and other risks and uncertainties are described more fully under the caption Risk Factors and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200324005120/en/

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Genprex Bolsters Board of Directors, Appoints Three Biotechnology and Healthcare Industry Leaders - BioSpace

ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics, Inc. (AgeX; NYSE American: AGE), a biotechnology company focused on developing therapeutics for human aging and regeneration, announced today that ImStem Biotechnology, Inc. (Farmington, CT), a biopharmaceutical company pioneering the development of mesenchymal stem cells (hES-MSC) derived from human embryonic stem cells has received notification from the U.S. Food and Drug Administration (FDA) that it has lifted the hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the treatment of multiple sclerosis (MS). IMS001 was derived from the pluripotential cell line designated ESI-053 licensed from AgeX.

Since pluripotent stem cells are capable of differentiating into all human cell types potentially genetically modified in any manner, they open the door to a wide array of new therapies, stated Dr. Michael D. West, PhD, founder and CEO of AgeX. This collaboration with ImStem is consistent with our aim to make our clinical-grade pluripotent stem cell banks widely available for diverse therapeutic applications.

IMS001 is a formulation of cells derived from AgeX pluripotent stem cells induced to differentiate into mesenchymal cells (hES-MSC) and through a proprietary method using a trophoblast intermediate stage (hence also known as T-MSC) for the treatment of neurological, autoimmune, and rare orphan diseases. IMS001 is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. ImStem believes this is the first hES-MSC based allogeneic cell therapy accepted for clinical trial by the FDA. ImStem plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.

The clinical-grade pluripotent stem cell lines from AgeX were the first published GMP-compatible lines ever created, said Xiaofang Wang, MD, PhD, Founder and Chief Technology Officer of ImStem. As such, they have been widely distributed in the scientific community and demonstrated to meet the needs of industry for relatively rapid product development.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly-defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeX is developing its core product pipeline for use in the clinic to extend human healthspan and is seeking opportunities to establish licensing and collaboration agreements around its broad IP estate and proprietary technology platforms.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About IMS001

IMS001 is an investigational, allogeneic, hES-MSC that has undergone IND-enabling, preclinical biodistribution, engraftment, tumorigenicity, toxicology, immunogenicity, and pharmacology studies. IMS001 has demonstrated preclinical immunomodulatory activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs.

Previously published in-vitro data, in collaboration with scientists at the University of Connecticut (UConn) Health, have demonstrated potential advantages of hESC-MSCs in terms of their immunomodulatory effects, as well as the potential to stabilize the blood-brain-barrier (BBB). These mechanistic properties may lead to therapeutic benefits in diseases such as MS, potentially reducing relapses, disability progression, and inducing disease arrest.

About ImStem Biotechnology

ImStem Biotechnology, Inc. is aspiring to revolutionize how serious diseases with significant unmet needs are treated with a new generation of regenerative and cellular therapies. Pioneering research by its current founder and Chief Technology Officer Dr. Xiaofang Wang and Dr. Ren-He Xu, former director of UConn Stem Cell Institute, led to the proprietary state-of-the-art pluripotent stem cell technology, enabling off-the-shelf, allogeneic stem cell-derived products to be manufactured in scale, differentiating itself from the typical challenges imposed by autologous adult cell therapy products. The companys mission is to advance the science and understanding of human pluripotent stem cell based regenerative cellular therapies through novel and creative development pathways and to fulfill unmet medical needs in serious diseases. And its development strategy focuses on neurologic, autoimmune, degenerative, and rare orphan diseases. ImStem Biotechnology, Inc. is a privately held company headquartered in Farmington, CT. For more information, visit http://www.imstem.com.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

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AgeX Therapeutics Licensee ImStem Biotechnology Announces FDA has Lifted the Hold and Cleared the Investigational New Drug Application for IMS001 for...

The 85 rating InvestorsObserver gives to Aytu Bioscience Inc (AYTU) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 99 percent of stocks in the Biotechnology industry, AYTUs 85 overall rating means the stock scores better than 85 percent of all stocks.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Aytu Bioscience Inc (AYTU) stock is down -16.08% while the S&P 500 has risen 3.65% as of 2:13 PM on Wednesday, Mar 25. AYTU has fallen -$0.32 from the previous closing price of $1.99 on volume of 21,555,025 shares. Over the past year the S&P 500 has fallen -10.00% while AYTU has risen 3.73%. AYTU lost -$1.88 per share the over the last 12 months.

To see the top 5 stocks in Biotechnology click here.

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Is Aytu Bioscience Inc (AYTU) a Winner or a Loser in the Biotechnology Industry - InvestorsObserver

The Global Agricultural Biotechnology For Transgenic Crops Market is expected to grow from USD 3,179.57 Million in 2018 to USD 9,904.57 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 17.62%.The latest report on Agricultural Biotechnology For Transgenic Crops Market added by Regal Intelligence, focus on market estimates and geographical spectrum of this industry. The report specifies information about Agricultural Biotechnology For Transgenic Crops industry regarding a thorough and detailed assessment of this business.

Further, the Agricultural Biotechnology For Transgenic Crops Market report details important challenges and factors that influence market growth. Further, a detailed comprehensive secondary research was done to collect information on the market segments and sub-segments. Further, primary research was performed to validate the assumptions and findings obtained from secondary research with industry professionals and experts.

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Competitive Landscape:

The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Agricultural Biotechnology For Transgenic Crops Market including are BASF SE, Bayer AG, Dow AgroSciences LLC, Monsanto Company, Pioneer Hi-Bred International, Inc., Agrilife, Land OLakes, Limagrain, Syngenta AG, and TAKII & CO.,LTD.. On the basis of Type, the Global Agricultural Biotechnology For Transgenic Crops Market is studied across Cisgenic, Multiple Trait Integration, Subgenic, and Transgenic.On the basis of Crop Type, the Global Agricultural Biotechnology For Transgenic Crops Market is studied across Cereals & Grains, Flowers, Fruits & Vegetables, Medicinal Herbs & Spices, and Oilseeds & Pulses.

In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this Agricultural Biotechnology For Transgenic Crops Market report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers, and producers etc.

The primary sources from the demand side include Agricultural Biotechnology For Transgenic Crops industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, End-User (product buyers), and related key executives from various key companies and organizations operating in the global Agricultural Biotechnology For Transgenic Crops market.

Primary Types of the industry are

Primary Applications of the industry are

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This report is based on the synthesis, analysis, and interpretation of information collected on the Agricultural Biotechnology For Transgenic Crops market from various sources. Our analysts have analysed the information & data and gained insights using a mix of primary and secondary research efforts with the primary objective to provide a holistic view of the Agricultural Biotechnology For Transgenic Crops Industry.

The following market parameters were considered to estimate market value:

Market Overview

The report includes overviews market introduction, market drivers & influencing factors, restraints & challenges, and potential growth opportunities of Agricultural Biotechnology For Transgenic Crops market. The report consists of market evaluation tools such as Porters five forces, PESTLE Analysis, and value chain analysis.

Key Questions Addressed in the Report:

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Agricultural Biotechnology For Transgenic Crops Market Opportunities and Threats faced by the Key Vendors 2025 - Monroe Scoop

Lets start up with the current stock price of Vir Biotechnology, Inc. (VIR), which is $30.85 to be very precise. The Stock rose vividly during the last session to $37.4 after opening rate of $37 while the lowest price it went was recorded $30.22 before closing at $32.75.

Price records that include history of low and high prices in the period of 52 weeks can tell a lot about the stocks existing status and the future performance. Presently, Vir Biotechnology, Inc. shares are logging -58.87% during the 52-week period from high price, and 164.80% higher than the lowest price point for the same timeframe. The stocks price range for the 52-week period managed to maintain the performance between $11.65 and $75.00.

The companys shares, operating in the sector of healthcare managed to top a trading volume set approximately around 562686 for the day, which was evidently lower, when compared to the average daily volumes of the shares.

When it comes to the year-to-date metrics, the Vir Biotechnology, Inc. (VIR) recorded performance in the market was 160.44%, having the revenues showcasing 166.91% on a quarterly basis in comparison with the same period year before. At the time of this writing, the total market value of the company is set at 4.13B, as it employees total of 217 workers.

During the last month, 2 analysts gave the Vir Biotechnology, Inc. a BUY rating, 0 of the polled analysts branded the stock as an OVERWEIGHT, 1 analysts were recommending to HOLD this stock, 1 of them gave the stock UNDERWEIGHT rating, and 0 of the polled analysts provided SELL rating.

According to the data provided on Barchart.com, the moving average of the company in the 100-day period was set at 20.80, with a change in the price was noted +16.66. In a similar fashion, Vir Biotechnology, Inc. posted a movement of +115.45% for the period of last 100 days, recording 527,790 in trading volumes.

Raw Stochastic average of Vir Biotechnology, Inc. in the period of last 50 days is set at 29.02%. The result represents improvement in oppose to Raw Stochastic average for the period of the last 20 days, recording 7.73%. In the last 20 days, the companys Stochastic %K was 19.17% and its Stochastic %D was recorded 29.17%.

Lets take a glance in the erstwhile performances of Vir Biotechnology, Inc., multiple moving trends are noted. Year-to-date Price performance of the companys stock appears to be pessimistic, given the fact the metric is recording 160.44%. The shares increased approximately by 1.54% in the 7-day charts and went down by -34.84% in the period of the last 30 days. Common stock shares were driven by 166.91% during last recorded quarter.

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Gear up for the change! Vir Biotechnology, Inc. (VIR) has hit the volume of 562686 - The InvestChronicle