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Killexams : CA-Technologies Administrator study - BingNews https://killexams.com/pass4sure/exam-detail/CAT-160 Search results Killexams : CA-Technologies Administrator study - BingNews https://killexams.com/pass4sure/exam-detail/CAT-160 https://killexams.com/exam_list/CA-Technologies Killexams : MediWound Enhances Its Board and Executive Leadership Team

MediWound Ltd.

Mr. Nachum Shamir appointed as Chairman of the Board

Dr. Robert Snyder appointed as Chief Medical Officer

YAVNE, Israel, Aug. 08, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the appointments of Mr. Nachum (Homi) Shamir as the Chairman of the Company’s Board of Directors and Dr. Robert Snyder as the Company’s Chief Medical Officer.

Mr. Shamir assumes the role of Chairman from Mr. Stephen T. Wills, who will remain on the Board as a Director. Dr. Snyder will assume his role as Chief Medical Officer on January 1, 2023. Professor Lior Rosenberg, founder and current Chief Medical Technology Officer, will continue to support the Company as a Medical Director focusing on the burn space and product life cycle management.

“We are excited to welcome our new Chairman of the board, Mr. Nachum Shamir and Dr. Rob Snyder as Chief Medical Officer. Both are significant appointments as we position ourselves for the next stage of growth at MediWound,” stated Ofer Gonen, Chief Executive Officer of MediWound. “Mr. Nachum Shamir has unique capabilities in bringing innovative medical technologies into global markets and building multi-billion-dollar companies.” Mr. Gonen added, “Dr. Rob Snyder’s role as Chief Medical Officer, will help us focus on advancing our EscharEx clinical development program. He has invaluable expertise, and a strong medical and scientific background. We look forward to benefitting from his leadership as we approach multiple upcoming clinical and regulatory milestones.”

Mr. Nachum Shamir said, "I am honored to chair the Board of Directors of MediWound as the Company leverages its innovative biotherapeutic solutions for tissue repair and regeneration. I believe the Company's novel technology holds tremendous potential, given the strong clinical data. I look forward to working with this astute team and supporting MediWound as it continues to advance its growing pipeline and I am committed to bringing value to our shareholders.”

Dr. Rob Snyder said, “It is a privilege to take on this role during such an exciting and transformative time for MediWound. I look forward to working with this outstanding management team as we focus our efforts on advancing our clinical pipeline. I am excited to be part of a company that will meaningfully Strengthen the lives of millions of patients worldwide.”

Mr. Nachum Shamir joins as Chairman of the MediWound Board with a proven track record of bringing game-changing technologies to the market. He most recently served as Chairman, President, CEO of Luminex Corporation (LMNX) prior to its acquisition in 2021 by DiaSorin for $1.8 billion. Mr. Shamir was President and CEO at Given Imaging (GIVN) from 2006 until its acquisition in 2014 by Covidien PLC (now Medtronic) for $1 billion. Prior to that, he was Corporate Vice President of Eastman Kodak and President of Eastman Kodak Transaction and Industrial Solutions Group. Mr. Shamir joined Eastman Kodak from Scitex Corporation where he held various executive positions, including President and CEO, prior to its acquisition in 2004 by Eastman Kodak for $262 million. Mr. Shamir has held senior management positions at various international companies, mainly in the Asia Pacific regions. He currently is a Board Member at Strata Skin Sciences (SSKN) and Chairman at Cactus Acquisition Corp. (CCTS). His previous Board appointments include Cogentix Medical (CGNT), which was acquired in 2018 by Laborie Medical Technologies for $214 million, and Invendo Medical GmbH, which was acquired in 2017 by Ambu for €225 million. Mr. Shamir holds a Bachelor of Science from the Hebrew University of Jerusalem and a Masters of Public Administration from Harvard University.

Dr. Robert J. Snyder (DPM, MSc, MBA, CWSP, FFPM RCPS) is Dean, Professor, Director of Clinical Research and Fellowship Director in Wound Care and Research at Barry University School of Podiatric Medicine. He is certified in foot and ankle surgery by the American Board of Podiatric Surgery and is also a board-certified wound specialist. Dr. Snyder is past-president of the Association for the Advancement of Wound Care and past-president of the American Board of Wound Management. Dr. Snyder has completed an MBA in Health Management from The George Washington University and the Global Clinical Scholars Research Training Program at Harvard Medical School. Dr. Snyder is a key opinion leader and sought-after speaker, lecturing extensively throughout the United States and abroad. He has published several book chapters and over 165 papers in peer reviewed and trade journals on wound care, and was the recipient of the Dr. Robert Warriner Memorial Award for excellence in wound management. Dr. Snyder serves as the Associate Editor for JAPMA and on the editorial advisory boards of Ostomy Wound Management, Wounds and as a periodic reviewer for the Lancet and NEJM. He has been a Principal Investigator on more than 65 randomized controlled trials for innovative wound healing modalities and products.

About MediWound Ltd.
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage with the Food and Drug Administration (FDA). NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

EscharEx, our next-generation bioactive topical therapeutic, is under development in the U.S. for debridement of chronic and hard to heal wounds. EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications in several Phase 2 trials. A meeting with the FDA to discuss the pivotal study design is targeted for the second half of 2022.

MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development. The initial data from a Phase I/II study showed MW005 to be safe and well-tolerated, with a majority of the patients who completed the study with MW005 achieving complete histological clearance of their target lesions. The Company anticipates announcing the final data in the second half of 2022.

Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control.  real results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the European Medicines Agency, FDA or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets. For Example, we cannot predict whether current geopolitical tensions between the U.S. and China will affect or delay the FDA’s ability to conduct inspection of the NexoBrid manufacturing facility located in Taiwan; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

Mon, 08 Aug 2022 08:05:00 -0500 en-CA text/html https://ca.sports.yahoo.com/news/mediwound-enhances-board-executive-leadership-200500510.html
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Tue, 03 Feb 2015 14:46:00 -0600 en text/html https://www.dal.ca/academics/programs/graduate/public-administration-management/curriculum/program-delivery.html
Killexams : Drug Taste Masking and Taste Assessment Services and Technologies Markets, 2035

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Dublin, July 28, 2022 (GLOBE NEWSWIRE) -- The "Taste Masking and Taste Assessment Services and Technologies Market, Distribution by Type of Formulation, Type of Techniques, Scale of Operation and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.

'Taste Masking and Taste Assessment Services and Technologies Market, 2022-2035 report features an extensive study of the current market landscape, offering an informed opinion on the taste masking and taste assessment services and technologies. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this field.

The oral solid dosage (OSD) market is the largest segment in the pharmaceutical industry, anticipated to reach over USD 900 billion by 2027.

However, one of key concerns associated with this industry is that the active pharmaceutical ingredients (APIs) used in orally administered dosage forms inherently possess an unpleasant taste/odour. The existence of such taste in drug formulations is unappealing and has been shown to have a negative impact on patient compliance, particularly among the pediatric and geriatric patient population.

In fact, in an event hosted by Adare Pharma Solutions and International Flavors and Fragrances (IFF), it has been reported that 30% to 40% of the pediatric population refuses to take a solid or liquid medication and about 26% of the geriatric population reports difficulty in swallowing tablets and capsules. Given the fact that there are numerous taste receptors on the tongue, it is difficult to block the taste of such drugs pharmacologically.

Therefore, in order to overcome the bitter taste of drugs, numerous conventional and novel taste masking techniques are being employed by pharmaceutical players; these include addition of sweeteners, coating, microencapsulation and hot-melt extrusion. Studies have suggested that application of taste masking technologies in oral drugs can increase the patience compliance from 53% to 90%.

Various pharmaceutical companies are actively investing time, capital and resources to develop palatable, pleasant-taste drug formulations, as well as a variety of taste-masking and assessment procedures for the drug dosage forms meant for children and elderly patients.

However, the overall process of development and assessment of taste-masked formulations is associated with several challenges, including variation in taste and its intensity in different APIs due to varying chemistries, identifying globally acceptable tastes, developing flavor matching placebo formulations (for testing) ensuring compliance with stringent regulatory guidelines and good clinical practices (GCPs), clinical research costs, and managing product life cycle.

The aforementioned reasons have prompted the pharmaceutical companies to outsource the taste masking and taste assessment related operations to third party service providers with expertise in this area.

Presently, 50 companies claim to offer services for taste-masking and taste-assessment, development and commercialization of taste masked formulations in compliance with the regulatory guidelines. Service providers also assist in assessment of taste masking agents in order to develop technologies suitable for wide range of formulations with different APIs.

Over time, centralized agencies, including the US Food and Drug Administration (US FDA) and European Medicines Agency (EMA) have streamlined efforts related to assessing the palatability of taste-masked drugs.

Additionally, the last few years have witnessed several strategic alliances between the players in this domain for expansion of existing taste masking capabilities to ensure drug formulations' palatability and commercial success.

Moreover, stakeholders are actively looking for patient-centric and age-appropriate dosage forms and novelexcipients. Given the ongoing efforts to enhance palatability of oral drug formulations, drug adherence and patient compliance, the taste-masking and taste assessment technologies and services market is likely to evolve at a steady pace in the next few years.

One of the key objectives of the report was to estimate the existing market size and future growth potential of the taste masking and taste assessment services and technologies market. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035.

Key Questions Answered

  • Who are the leading players engaged in providing taste masking and taste assessment services and technology platforms?

  • Which companies offer taste masking technologies for licensing?

  • What kind of partnership models are commonly adopted by industry stakeholders?

  • What is the relative competitiveness of different taste masking and taste assessment service providers based in different geographies?

  • How has the intellectual property landscape in this field evolved over the years?

  • How is the current and future opportunity, related to taste masking and taste assessment likely to be distributed across key market segments?

Key syllabus Covered:

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Bitterness of Oral Drugs and Need for Taste Masking
3.3. Physiology of Taste Buds
3.4. Concept of Taste Masking
3.5. Introduction to Taste Assessment

4. TASTE MASKING AND TASTE ASSESSMENT SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Taste Masking and Taste Assessment Service Providers
4.3. Taste Masking and Taste Assessment Services: Overall Market Landscape

5. TASTE MASKING AND TASTE ASSESSMENT TECHNOLOGY PROVIDERS: MARKET LANDSCAPE
5.1. Chapter Overview
5.2. Taste Masking and Taste Assessment Technologies: Overall Market Landscape
5.2.1. Analysis by Type of Service(s) Offered
5.2.2. Analysis by Technique(s) Used
5.2.3. Analysis by Type of Formulation
5.2.4. Analysis by End users
5.3. Taste Masking and Taste Assessment Technology Providers
5.3.1. Analysis by Year of Establishment
5.3.2. Analysis by Company Size
5.3.3. Analysis by Location of Headquarters
5.3.4. Analysis by Year of Establishment and Location of Headquarters
5.3.5. Analysis by Company Size and Location of Headquarters
5.3.6. Leading Players: Analysis by Number of Technologies

6. TASTE MASKING AND TASTE ASSESSMENT SERVICE PROVIDERS: COMPANY PROFILES
6.1. Chapter Overview
6.2. AbbVie
6.2.1. Company Overview
6.2.2. Financial Information
6.2.3. Taste Masking and Taste Assessment Service Portfolio
6.2.4. exact Developments and Future Outlook
6.3. Catalent
6.4. Fertin Pharma
6.5. Lonza
6.6. NextPharma
6.7. Patheon
6.8. Quotient Sciences
6.9. Senopsys

7. TASTE MASKING AND TASTE ASSESSMENT TECHNOLOGY PROVIDERS: COMPANY PROFILES
7.1. Chapter Overview
7.2. Adare Pharma Solutions
7.2.1. Company Overview
7.2.2. Taste Masking and Taste Assessment Technology Portfolio
7.2.3. exact Developments and Future Outlook
7.3. Colorcon
7.4. Lupin
7.5. Mayne Pharma

8. COMPANY COMPETITIVENESS ANALYSIS
8.1. Chapter Overview
8.2. Methodology and Key Parameters
8.3. Taste Masking and Taste Assessment Service Providers

9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. Taste Masking and Taste Assessment: List of Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Collaboration
9.3.3. Analysis by Year and Type of Collaboration
9.3.4. Analysis by Type of Partner
9.3.5. Analysis by Type of Partner and Year of Partnership
9.3.6. Analysis by Type of Service(s) Offered
9.3.7. Analysis by Scale of Operation
9.3.8. Analysis by Type of Formulation
9.3.9. Regional Analysis
9.3.10. Most Active Players based on Number of Partnerships

10. PATENT ANALYSIS
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Patent Benchmarking Analysis
10.4. Patent Valuation Analysis
10.5. Leading Patents based on Number of Citations

11. CASE STUDY: EXCIPIENTS USED IN PHARMACEUTICAL TASTE MASKING
11.1. Chapter Overview
11.2. Types of Pharmaceutical Excipients
11.3. Pharmaceutical Taste Masking Excipients: Overall Market Landscape
11.4. Pharmaceutical Taste Masking Excipient Providers: Market Landscape

12. MARKET SIZING AND OPPORTUNITY ANALYSIS
12.1. Chapter Overview
12.2. Key Assumptions and Forecast Methodology
12.3 Taste Masking and Taste Assessment Services Market, 2022-2035
12.4. Taste Masking and Taste Assessment Services Market, 2022-2035: Distribution by Scale of Operation
12.5. Taste Masking and Taste Assessment Services Market, 2022-2035: Distribution by Geographical Regions

13. CONCLUDING REMARKS

14. EXECUTIVE INSIGHTS
14.1. Chapter Overview
14.2. Glatt Pharmaceutical Services
14.3 Senopsys
14.4. Adare Pharma Solutions

15. APPENDIX 1: TABULATED DATA

16. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Companies Mentioned

  • Aavis Pharmaceuticals

  • AbbVie

  • Adare Pharma Solutions

  • Allergan

  • Alpex Pharma

  • Aprecia Pharmaceuticals

  • Aquestive Therapeutics (formerly known as MonoSol Rx)

  • Arcinova

  • Ash Stevens

  • ATHENA Pharmaceutiques

  • Aurigene

  • Avista Pharma Solutions

  • axapharm

  • Azelis Americas

  • Battelle

  • BioGeneration Ventures

  • Biohaven Pharmaceutical Holding Company

  • Bionpharma

  • Bridge Therapeutics

  • BroadOak Capital Partners

  • Cambrex

  • Capsugel

  • Catalent

  • Chiasma

  • CMIC Group

  • Coating Place

  • Colorcon

  • Commonwealth Scientific and Industrial Research Organisation

  • CordenPharma

  • CoreRx

  • CrystecPharma

  • Cybin

  • Cynapsus Therapeutics

  • Edenbridge Pharmaceuticals

  • Egalet

  • Emerald Health Pharmaceutical

  • ESSA Pharma

  • Ethicann Pharmaceuticals

  • Evotec

  • Farragut

  • Fertin Pharma

  • Fluid Pharma

  • Forbion

  • ForTe-bv (sunsidiary of ForTe IQ bv)

  • Frazier Healthcare Partners

  • Frontida BioPharm (acquired by Adare Pharma Solutions)

  • G&W Laboratories

  • GALENIX

  • GB Sciences

  • Glatt Pharmaceutical Services

  • Globela Pharma

  • Glycologic

  • GPT Pharma

  • Haisco Pharmaceutical

  • Halo Pharma

  • HARKE Pharma

  • HERMES PHARMA

  • Hovione

  • i2o Therapeutics

  • Ideal Cures

  • InnovaNutra

  • Innovation Pharmaceuticals

  • INPHARMASCI (acquired by ATHENA)

  • Jubilant Pharma

  • Kola Pharma

  • Korsch

  • Lonza

  • Losan Pharma

  • Lubrizol Life Science Health

  • Lupin

  • Lyne Laborataries

  • Mayne Pharma

  • Medis

  • Metrics Contract Services

  • Mikart

  • Mithra Pharmaceuticals

  • Mitsubishi Tanabe Pharma

  • Nanoform

  • Nautic Partners

  • Nextar

  • NextPharma

  • Novast

  • Nucleo Life Sciences (acquired by CoreRx)

  • Opertech Bio

  • Orbis Biosciences

  • Oxford Pharmascience

  • Particle Dynamics

  • Patheon

  • Paulaur

  • Pensatech Pharma

  • Pfizer

  • Pharmaceutical Manufacturing Research Services

  • Pharmaceutical Product Development

  • Pharmaterials

  • Phathom Pharmaceuticals

  • Phil

  • Philip Morris International

  • Piramal Pharma Solutions

  • ProCepT

  • Purdue University

  • Quay Pharma

  • Quotient Sciences

  • RedHill Biopharma

  • Research Corporation Technologies

  • Rubicon Research

  • Senopsys

  • SGS

  • Shire

  • SkyePharma

  • SPI Pharma

  • SRLPharma

  • Stabicon Life Sciences

  • Sunvij Drugs

  • TasteTech

  • Teva Pharmaceuticals

  • Therabel

  • Thermo Fisher Scientific

  • Thomas H. Lee Partners

  • University of Hertfordshire

  • UPM Pharmaceuticals

  • Vertex Pharmaceuticals

  • Vifor Pharma

  • Wellesta Holdings

  • Xedev

  • ZIM Laboratories

For more information about this report visit https://www.researchandmarkets.com/r/tqsx31

CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Wed, 27 Jul 2022 21:38:00 -0500 en-CA text/html https://ca.style.yahoo.com/drug-taste-masking-taste-assessment-093800458.html
Killexams : Maxar Awarded GeoXO Spacecraft Phase A Study Contract for NOAA’s Next-Generation Weather Monitoring Satellites

WESTMINSTER, Colo., August 04, 2022--(BUSINESS WIRE)--Maxar Technologies (NYSE:MAXR) (TSX:MAXR), provider of comprehensive space solutions and secure, precise, geospatial intelligence, announced it received a Phase A study contract from NASA for the National Oceanic and Atmospheric Administration’s (NOAA) Geostationary Extended Observations (GeoXO) Spacecraft mission. During the ten-month contract, Maxar will develop the spacecraft concept, mature necessary technologies, conduct analysis on robotic servicing and payload accommodations, help define the potential performance, risks, costs and development schedule for a three-satellite, next-generation constellation of weather monitoring satellites.

"Maxar is excited to work on designing NOAA’s next-generation weather monitoring spacecraft," said Chris Johnson, Maxar Senior Vice President and General Manager of Space. "This contract builds on our legacy of manufacturing the first- and second-generation GOES satellites, which operated beyond their expected lifetimes. Maxar is committed to helping customers use spacecraft and space-based data to study weather patterns and mitigate climate change, and this GeoXO study contract is the next evolution of that work."

Maxar’s flight-proven 1300-class platform serves as the basis for the company’s Phase A Study contract. Today, there are 90 Maxar-built spacecraft operating on orbit that use the 1300-class platform. This platform provides the precision, stability, reliability and assured operations that NOAA requires for the GeoXO mission.

The GeoXO program will continue Earth observations from geostationary orbit, providing vital information to address major environmental challenges in the United States. GeoXO will also leverage new capabilities to address emerging climate issues that threaten the security and well-being of every American.

Maxar previously built the first-generation and second-generation Geostationary Operational Environmental Satellites (GOES), which were known for their high performance, longevity and reliability. Contracted to build a constellation of three satellites in the 1970s, Maxar (then Ford Aerospace) built GOES-A, -B and -C for NASA’s Office of Space Science Applications. They were later renamed GOES 1, 2 and 3. Maxar also manufactured five more weather monitoring satellites for NOAA: GOES 8, 9, 10, 11 and 12, which were launched in the late 1990s and early 2000s.

About Maxar

Maxar Technologies (NYSE:MAXR) (TSX:MAXR) is a provider of comprehensive space solutions and secure, precise, geospatial intelligence. We deliver disruptive value to government and commercial customers to help them monitor, understand and navigate our changing planet; deliver global broadband communications; and explore and advance the use of space. Our unique approach combines decades of deep mission understanding and a proven commercial and defense foundation to deploy solutions and deliver insights with unrivaled speed, scale and cost effectiveness. Maxar’s 4,400 team members in over 20 global locations are inspired to harness the potential of space to help our customers create a better world. Maxar trades on the New York Stock Exchange and Toronto Stock Exchange as MAXR. For more information, visit www.maxar.com.

Forward-Looking Statements

This press release may contain forward-looking statements that reflect management's current expectations, assumptions and estimates of future performance and economic conditions. Any such forward-looking statements are made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company cautions investors that any forward-looking statements are subject to risks and uncertainties that may cause real results and future trends to differ materially from those matters expressed in or implied by such forward-looking statements, including those included in the Company’s filings with U.S. securities and Canadian regulatory authorities. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as may be required under applicable securities law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220804005965/en/

Contacts

Investor Relations Contact:
Jonny Bell
Maxar Investor Relations
1-303-684-5543
jonny.bell@maxar.com

Media Contact:
Kristin Carringer
Maxar Media Relations
1-303-684-4352
kristin.carringer@maxar.com

Thu, 04 Aug 2022 08:30:00 -0500 en-CA text/html https://ca.news.yahoo.com/maxar-awarded-geoxo-spacecraft-phase-203000026.html
Killexams : Aptima Awarded U.S. Air Force Contract for Evaluating Pilot Training for Electric Vertical Takeoff and Landing (eVTOL) Aircraft

Aptima, Inc.

They’re not airplanes. They’re not helicopters. What skills will pilots need to fly eVTOLs?

WOBURN, Mass., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Electric Vertical Takeoff and Landing (eVTOL) aircraft will soon transform the skies above. But who will fly these new and novel vehicles, what skills will they need, and how will they be trained to operate platforms that feature new levels of automation?

To help answer those questions, Aptima, Inc., has been awarded a contract by the US Air Force to assist the Air Education and Training Command’s Detachment 62 (Det 62) to determine the pilot proficiencies and training needed for eVTOL operators. Det 62 supports the AFWERX Agility Prime program and is charged with developing the curriculum for eVTOL pilots and driving certification standards for an emerging market that is expected to transform civil air mobility and select military missions.

Using simulators of various eVTOL prototypes, Aptima will assess and identify the pilot competencies needed for proficient flight, including how pilots learn and perform on eVTOL platforms that have varying levels of automation. “The learnability study will help us not only understand the baseline pilot skills and competencies needed for proficient eVTOL flight, but also the impact of automation on pilot performance,” said Samantha Emerson, Training, Learning & Readiness Scientist at Aptima, and project manager for the contract. “Both experienced and novice pilots will bring unique sets of skills and capacities based on their experiences and abilities. We’ll assess how these differences affect performance in aircraft with various levels of automation”.

EVTOL prototypes range from having moderate levels of automation, that still fly like typical aircraft, to higher orders of automation, thus raising questions about the skills and training required to fly them.

In more heavily automated platforms, where pilots mostly control flight settings rather than the aircraft itself, preliminary research suggests experienced pilots tend to have more difficulty adjusting to automation than novice pilots. This is why we will look to see if experienced pilots tend to “overcontrol” of the aircraft.

“Even though a more experienced pilot may possess greater ability in controlling aircraft, not all those skills may be useful or even desired in platforms with more automation and augmentation. In fact, it may require an ‘unlearning’ and re-training of behaviors to prevent interference or conflict with automated operations,” Emerson added.

Aptima, a leader in human-machine teaming and training, will help evaluate how automation affects pilots in different eVTOLs, which existing skills will be transferable, and what new skills will require training.

Applying AFRL Technologies to eVTOL Training

To assess pilot learning and performance, Aptima will use technologies and techniques it has developed with the Air Force Research Laboratory (AFRL) over the past 15 years to measure, analyze, understand, and optimize Airman performance. These include the Performance Evaluation Training System, or PETS, which harvests data from simulators to provide objective, system-based measures, and SPOTLITE, Aptima’s handheld tool used by subject matter experts to provide observer-based measures of performance.

“Together, the objective measures from simulators and the subjective measures from what experts recognize as “good flying” produce a more complete picture of pilot learning and performance.” These findings will help Det 62 test and evaluate its eVTOL training assumptions. The findings could also influence how aircraft manufacturers design platforms in the future as we discover which aspects of flight benefit most from improved automation.

This work is funded by the U.S. Air Force via the General Services Administration under Solicitation Number 47QFLA22Q0077 / GSA ID# 47QFLA19K0069-0006 entitled, “AETC Det 62 eVTOL: Agility Prime Training Assessment Technologies for Electric Vertical Takeoff and Landing (eVTOL) Vehicles,” funded by Col Don “Stryker” Haley and Dr. Stephen B. Ellis, whom the authors wish to thank for their support.

CONTACT: Media Contact: Joel Greenberg DCPR joel@dcpr.com 202-363-1065 | 202-669-3639 cell
Mon, 08 Aug 2022 06:46:00 -0500 en-CA text/html https://ca.sports.yahoo.com/news/aptima-awarded-u-air-force-184600217.html
Killexams : PDS Biotech Reports Second Quarter 2022 Financial Results and Provides Business Update

PDS Biotechnology Corporation

  • Announced results from two of the ongoing Phase 2 clinical trials of PDS0101 in multiple, difficult-to-treat HPV16-related cancers presented at the American Society of Clinical Oncology meeting

  • Promising pre-clinical data on universal flu vaccine program presented at American Society of Virology meeting

  • Company to host conference call and webcast today at 8:00 AM EDT

FLORHAM PARK, N.J., Aug. 08, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T cell-activating technologies, will discuss its financial results for the quarter ended June 30, 2022 and provide a business update on its conference call today.

Recent Business Highlights:

  • Granted Fast Track Designation by U.S. Food and Drug Administration (FDA) for PDS0101 in combination with KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

  • Presented data from 17 evaluable patients (efficacy) enrolled in the VERSATILE-002 Phase 2 clinical trial at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, demonstrating clinical efficacy (objective response rate [ORR] plus stable disease) in 76.5% of patients.

  • Announced acceptance of clinical trial application to expand VERSATILE-002 Phase 2 trial of PDS0101 in combination with KEYTRUDA® (pembrolizumab) into the United Kingdom.

  • Presented data from 30 patients enrolled in National Cancer Institute-led triple combination Phase 2 clinical trial of PDS0101 in advanced, refractory HPV-positive cancers at ASCO 2022:

    • 88% of checkpoint inhibitor (CPI)-naïve patients achieving an ORR (tumor shrinkage >30%). In published studies with CPI monotherapy, ORR ranged from 13-24%.

    • 77% of CPI refractory patients were alive at a median of 12 months. In published studies, historical median survival rates for CPI refractory patients is 3-4 months. 

  • Presented data from pre-clinical universal flu vaccine program at the American Society of Virology meeting, demonstrating the ability of PDS0202, the Company’s Infectimune™ candidate formulated with Computationally Optimized Broadly Reactive Antigens (or COBRA) influenza antigens, to neutralize multiple strains of influenza, including H1N1, and provide protection against infection with lethal challenge in animals. 

  • Strengthened leadership team with addition of Spencer Brown as Senior Vice President and General Counsel, and Sanjay Zaveri as Senior Vice President, Business Development.

“We made tremendous progress this quarter with our lead candidate, PDS0101, across all four ongoing Phase 2 clinical trials, and also with our advancing oncology pipeline candidates PDS0102 and PDS0103,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “Our clinical data at this year’s ASCO meeting not only solidified our confidence in our Versamune™ platform, but also in the potential of PDS0101 to make a meaningful difference in the treatment of advanced HPV16-positive cancer patients with significant unmet needs. With these data, we are hopeful that our upcoming meetings with the FDA will clarify our regulatory path forward for PDS0101.”

Dr. Bedu-Addo further commented, “We are also encouraged by the pre-clinical data from our PDS0202 universal flu vaccine candidate which we believe has the potential to transform the global approach to protecting the population against the flu virus. We believe we are well positioned to continue our drive to deliver significant value to both patients and our shareholders.”

Second Quarter 2022 Financial Results
Net loss for the three months ended June 30, 2022 was approximately $5.8 million, or ($0.20) per basic share and diluted share, compared to a net loss of approximately $0.6 million, or ($0.03) per basic share and diluted share, for the three months ended June 30, 2021. The higher net loss reported for the three months ended June 2022 is primarily due to additional costs for expansion of the Company’s research and development, including costs associated with our ongoing clinical trials, additional general and administrative costs, and lower income tax benefit.

Research and development expenses increased to $3.8 million for the three months ended June 30, 2022 from $2.8 million for the three months ended June 30, 2021. The increase of $1.0 million in 2022 was primarily attributable to an increase of $0.4 million in clinical study and research costs, $0.7 million in personnel costs, and $0.1 million in facilities, partially offset by a decrease of $0.2 million in manufacturing services.

General and administrative expenses increased to $3.3 million for the three months ended June 30, 2022 from $2.3 million for the three months ended June 30, 2021. The increase of $1.0 million is primarily attributable to an increase of $0.8 million in personnel costs and $0.2 million in legal fees.

Total operating expenses were approximately $7.1 million for the three months ended June 30, 2022, from approximately $5.1 million for the three months ended June 30, 2021.

PDS Biotech’s cash balance as of June 30, 2022 was approximately $53.0 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT today, August 8, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13731437. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. real results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including record inflation, unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19 and the ongoing military conflict between Russia and Ukraine. The foregoing review of important factors that could cause real events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital


PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY

Condensed Consolidated Balance Sheets

June 30, 2022

December 31, 2021

ASSETS

(unaudited)

Current assets:

Cash and cash equivalents

$

52,984,672

$

65,242,622

Prepaid expenses and other

2,757,910

1,597,569

Total current assets

55,742,582

66,840,191

Property and equipment, net

-

86

Operating lease right-to-use asset

258,188

357,611

Total assets

$

56,000,770

$

67,197,888

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable

$

1,877,991

$

1,309,403

Accrued expenses

2,302,921

2,187,704

Operating lease obligation-short term

335,012

258,924

Total current liabilities

4,515,924

3,756,031

Noncurrent liability:

Operating lease obligation-long term

59,650

231,430

Total Liabilities:

$

4,575,574

$

3,987,461

STOCKHOLDERS' EQUITY

Common stock, $0.00033 par value, 75,000,000 shares authorized at June 30, 2022 and December 31, 2021, 28,458,688 shares and 28,448,612 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively

9,391

9,387

Additional paid-in capital

126,412,089

123,904,602

Accumulated deficit

(74,996,284

)

(60,703,562

)

Total stockholders' equity

51,425,196

63,210,427

Total liabilities and stockholders' equity

$

56,000,770

$

67,197,888


PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ended June 30,

Six Months Ended June 30,

2022

2021

2022

2021

Operating expenses:

Research and development expenses

$

3,761,646

$

2,764,195

$

8,922,961

$

4,177,252

General and administrative expenses

3,331,006

2,341,828

6,648,913

3,978,044

Total operating expenses

7,092,652

5,106,023

15,571,874

8,155,296

Loss from operations

(7,092,652

)

(5,106,023

)

(15,571,874

)

(8,155,296

)

Interest income

74,547

604

80,247

1,259

Loss before income taxes

(7,018,105

)

(5,105,419

)

(15,491,627

)

(8,154,037

)

Benefit for income taxes

1,198,905

4,516,488

1,198,905

4,516,488

Net loss and comprehensive loss

(5,819,200

)

(588,931

)

(14,292,722

)

(3,637,549

)

Per share information:

Net loss per share, basic and diluted

$

(0.20

)

$

(0.03

)

$

(0.50

)

$

(0.16

)

Weighted average common shares outstanding, basic, and diluted

28,451,579

23,160,371

28,450,104

22,714,581


PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY

Condensed Consolidated Statements of Cash Flows

(Unaudited)

Six Months Ended June 30,

2022

2021

Cash flows from operating activities:

Net loss

$

(14,292,722

)

$

(3,637,549

)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation expense

2,477,574

699,219

Stock-based 401K company common match

-

35,747

Depreciation expense

86

3,133

Operating lease expense

120,514

120,514

Changes in assets and liabilities:

Prepaid expenses and other assets

(1,160,341

)

(687,524

)

Accounts payable

568,588

960,139

Accrued expenses

115,217

(265,530

)

Operating lease liabilities

(116,783

)

(84,115

)

Net cash used in operating activities

(12,287,867

)

(2,855,966

)

Cash flows from financing activities:

Proceeds from exercise of stock options

29,917

220,603

Proceeds from issuances of common stock, net of issuance costs

-

48,544,998

Net cash provided by financing activities

29,917

48,765,601

Net (decrease) increase in cash and cash equivalents

(12,257,950

)

45,909,635

Cash and cash equivalents at beginning of period

65,242,622

28,839,565

Cash and cash equivalents at end of period

$

52,984,672

$

74,749,200

Sun, 07 Aug 2022 23:00:00 -0500 en-CA text/html https://ca.finance.yahoo.com/news/pds-biotech-reports-second-quarter-110000922.html
Killexams : Editas Medicine Announces Second Quarter 2022 Results and Business Updates

Appointed Baisong Mei, M.D., Ph.D., Chief Medical Officer, strengthening senior leadership team

Achieved successful engraftment of first patient treated with EDIT-301 for sickle cell disease; first clinical use of Editas-engineered AsCas12a enzyme

FDA removed partial clinical hold for RUBY trial of EDIT-301

Continued screening and enrolling new adult and pediatric patients for EDIT-101 Phase 1/2 BRILLIANCE study for LCA10, with clinical data update expected 2H 2022

On track to initiate IND-enabling studies of EDIT-103 for RHO-adRP by year-end; pre-IND FDA meeting feedback supports continued development

Entered research collaboration and licensing agreement with Immatics to develop cancer medicines, combining Immatics gamma-delta T cell adoptive cell therapies and Editas Medicine’s gene editing technology

CAMBRIDGE, Mass., Aug. 03, 2022 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today reported business highlights and financial results for the second quarter of 2022.

“Since joining Editas Medicine two months ago, my review of the innovative technologies, strong CMC capabilities, and talented team has reinforced my enthusiasm about the company’s potential. I see tremendous value in our technology and ability to develop novel medicines, and I intend to focus our efforts on transforming the business from a technology platform company into a therapeutics company,” said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine. “In addition, I’m excited to welcome our new Chief Medical Officer, Dr. Baisong Mei, to the leadership team, where he will utilize his deep experience in developing therapeutics from pre-clinical stages through global approvals to assist in this transformation.”

Recent Achievements and Outlook

Ex Vivo Gene Edited Medicines

  • EDIT-301 for Sickle Cell Disease
    First SCD patient treated with EDIT-301 successfully engrafted and demonstrated positive initial safety profile
  • Editas Medicine dosed the first patient and confirmed successful neutrophil and platelet engraftment in the Phase 1/2 RUBY trial for the treatment of severe sickle cell disease (SCD).
  • This is the first time that the Company’s engineered AsCas12a enzyme has been used to edit human cells in a clinical trial.
  • The Company is enrolling additional study participants, has successfully edited CD34+ cells from patients in preparation for reinfusion, and remains on track to announce top-line clinical data by year-end. 

  FDA removed partial clinical hold for RUBY trial of EDIT-301 for SCD

  • The Company also announced that in July the U.S. Food and Drug Administration (FDA) removed the previously disclosed partial clinical hold for EDIT-301 RUBY study for the treatment of SCD. This enables Editas Medicine to include patients’ efficacy data in a marketing application for EDIT-301 in the future.
  • EDIT-301 for TDT
    Received FDA Orphan Drug Designation; first patient dosing remains on track for 2022
  • In May, the FDA granted Orphan Drug Designation to EDIT-301 for the treatment of transfusion-dependent beta thalassemia (TDT).
  • Preparations to initiate the Phase 1/2 clinical trial designed to assess the safety, tolerability, and preliminary efficacy of EDIT-301 for the treatment of TDT are underway, and the Company remains on track to dose the first TDT patient in 2022.

In Vivo  Gene Edited Medicines 

  • EDIT-101 for LCA10
    Additional pediatric and adult patients dosed in BRILLIANCE trial; continued screening and enrollment of pediatric and adult patients; on track for clinical update in second half of 2022
  • Editas Medicine has completed dosing of the second patient in the pediatric mid-dose cohort and continues to screen and enroll new pediatric patients in the ongoing EDIT-101 BRILLIANCE trial for Leber Congenital Amaurosis 10 (LCA10), a CEP290-related retinal degenerative disorder.
  • The Company also continues to dose new patients in the study’s expanded adult cohorts.
  • Editas Medicine remains on track to provide a clinical update on the BRILLIANCE trial in the second half of 2022.
  • EDIT-103 for RHO-adRP
    On track to initiate IND-enabling studies by year-end; pre-IND FDA meeting feedback supports continued development
  • Editas Medicine remains on track to initiate IND-enabling studies for EDIT-103 by year-end. Following feedback from a pre-IND meeting with the FDA, the Company is continuing development of EDIT-103, which utilizes a unique in vivo knockout and replace mechanism, for the treatment of rhodopsin-associated autosomal dominant retinitis pigmentosa (RHO-adRP), a progressive form of retinal degeneration.
  • In May, Editas Medicine presented preclinical data at the Association for Research in Vison and Ophthalmology (ARVO) Annual Meeting, demonstrating nearly 100% gene editing knockout of the endogenous RHO gene and the replacement RHO gene produced over 30% of normal RHO protein levels in the treated area of subretinal injection in non-human primates (NHPs) treated with EDIT-103. Furthermore, EDIT-103-injected eyes of NHPs showed restoration of RHO expression in the outer segments and retention of normal photoreceptor structure and function compared to the knockout-only-injected eye.

Cellular Therapy

  • Gamma-Delta T Cells for Oncology
    Collaboration with Immatics to combine gamma-delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer
  • In June, 2022, Editas Medicine and Immatics N.V. announced a strategic research collaboration and licensing agreement to combine gamma-delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer.
  • As part of the licensing agreement, Immatics gains non-exclusive rights to Editas Medicine’s CRISPR technology and intellectual property. By combining Editas Medicine’s gene editing technology with Immatics’ ACTallo® allogeneic, off-the-shelf adoptive cell therapy platform based on gamma-delta T cells, gamma-delta T cells may be redirected to cancer cell targets with the goal of creating cells with enhanced tumor recognition and destruction.
  • Editas Medicine received an undisclosed upfront cash payment and is eligible to receive additional payments based on development, regulatory, and commercial milestones. In addition, Immatics will pay royalties on future net sales on any products that may result from this collaboration.
  • Alpha-Beta T Cells for Oncology
    Bristol Myers Squibb opted into eighth genome editing program for alpha-beta T cell program
  • Bristol Myers Squibb recently opted into an additional gene editing program, marking the eighth program opted into by Bristol Myers Squibb since the start of the collaboration, one of which has advanced to development candidate status.
  • The ongoing collaboration between Editas Medicine and Bristol Myers Squibb continues to advance alpha-beta T cell investigational medicines for the treatment of solid and liquid tumors, leveraging Editas Medicine’s unique platform technologies, including SpCas9 and AsCas12a.

Corporate Updates

  • Senior Leadership Strengthened with CMO Appointment
    On July 18, 2022, the Company announced the appointment of Baisong Mei, M.D., Ph.D., as Chief Medical Officer. During his career, Dr. Mei has demonstrated a strong track record in bringing novel medicines through clinical development and approval. Dr. Mei joined Editas Medicine from Sanofi, where he served as Senior Global Project Head in Rare Disease and Rare Blood Disorders.

Second Quarter 2022 Financial Results

  • Cash, cash equivalents, and marketable securities as of June 30, 2022, were $527.6 million, compared to $566.4 million as of March 31, 2022. The Company expects that its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditures into 2024.
  • For the three months ended June 30, 2022, net loss attributable to common stockholders was $53.5 million, or $0.78 per share, compared to net loss of $55.3 million, or $0.81 per share, for the same period in 2021.
  • Collaboration and other research and development revenues were $6.4 million for the three months ended June 30, 2022, compared to $0.4 million for the same period in 2021. The increase was primarily attributable to the additional program licensed by Bristol Myers Squibb in the second quarter of 2022.
  • Research and development expenses increased by $9.9 million to $43.7 million for the three months ended June 30, 2022, from $33.8 million for the same period in 2021. The increase was primarily related to increased manufacturing and clinical-related expenses related to the Company’s ongoing clinical trials, license obligations related to a clinical milestone achievement, employee-related expenses for workforce expansion, and increased expenses due to sublicense fees.
  • General and administrative expenses decreased by $5.1 million to $16.9 million for the three months ended June 30, 2022, from $22.0 million for the same period in 2021. The decrease was primarily attributable to the performance awards granted in 2021 to our former Chief Executive Officer that were achieved or deemed probable in the second quarter of 2021, for which there was no similar expense during the three months ended June 30, 2022.

Upcoming Events

Editas Medicine plans to participate in the following investor events:

  • Wells Fargo Healthcare Conference, September 7, Boston, MA
  • Morgan Stanley Global Healthcare Conference, September 12, New York, NY
  • Baird Global Healthcare Conference, September 13, New York, NY

Conference Call
The Editas Medicine management team will host a conference call and webcast today at 8:00 a.m. ET to provide and discuss a corporate update and financial results for the second quarter of 2022. To access the call, please dial 877-407-0989 (domestic) or 201-389-0921 (international) and ask for the Editas Medicine earnings call. A live webcast of the call will also be available on the Investors section of the Editas Medicine website at www.editasmedicine.com, and a replay will be available approximately two hours after its completion.

About Editas Medicine
As a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Harvard and Broad Institute’s Cas9 patent estates and Broad Institute’s Cas12a patent estate for human medicines. For the latest information and scientific presentations, please visit www.editasmedicine.com.

Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the initiation, timing, progress and results of the Company’s preclinical and clinical studies and its research and development programs, including dosing the first TDT patient with EDIT-301 in 2022 and initiating IND-enabling studies of EDIT-103 for RHO-adRP by year-end 2022, the timing for the Company’s receipt and presentation of data from its clinical trials and preclinical studies, including top-line clinical data from the RUBY trial by year-end 2022 and a clinical update on the BRILLIANCE trial in the second half of 2022, the timing or likelihood of regulatory filings and approvals, and the Company’s expectations regarding cash runway. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. real results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials, including the BRILLIANCE and RUBY trials, and clinical development of the Company’s product candidates; availability and timing of results from pre-clinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most exact Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release represent Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements.

EDITAS MEDICINE, INC.
Consolidated Statement of Operations
(amounts in thousands, except share and per share data)
(Unaudited)

  Three Months Ended
Six  Months Ended
  June 30,
June 30,
  2022     2021
    2022
    2021  
 
Collaboration and other research   
and development revenues   $ 6,362     $ 379     $ 13,134     $ 6,878  
Operating expenses:       
Research and development     43,659       33,753       81,635       75,690  
General and administrative     16,937       22,027       36,483       43,471  
Total operating expenses     60,596       55,780       118,118       119,161  
Operating loss     (54,234 )     (55,401 )     (104,984 )     (112,283 )
Other income, net:      
Other income(expense), net     235       (1 )     1       19  
Interest income, net     546       146       1,015       280  
Total other income, net     781       145       1,016       299  
Net loss   $ (53,453 )   $ (55,256 )   $ (103,968 )   $ (111,984 )
Net loss per share attributable      
to common stockholders,      
basic and diluted   $ (0.78 )   $ (0.81 )   $ (1.52 )   $ (1.67 )
Weighted-average common      
shares outstanding, basic and      
diluted   68,640,858     67,877,126     68,563,348     66,939,967  
                         

EDITAS MEDICINE, INC.
Selected Consolidated Balance Sheet Items
(amounts in thousands)
(Unaudited)

  June 30,   December 31,
  2022   2021
 
Cash, cash equivalents, and marketable securities   $ 527,620   $ 619,916
Working capital     424,956     460,426
Total assets     580,833     677,483
Deferred revenue, net of current portion     68,888     60,888
Total stockholders' equity     465,414     553,642

Media Contact:
Cristi Barnett
(617) 401-0113
cristi.barnett@editasmed.com  

Investor Contact:
Ron Moldaver
(617) 401-9052
ir@editasmed.com  

 

Tue, 02 Aug 2022 22:32:00 -0500 en text/html https://apnews.com/press-release/globe-newswire/science-technology-health-cancer-e6eae86844c952f8a3bd9597ca777265
Killexams : LITE ACCESS TECHNOLOGIES ANNOUNCES APPOINTMENT OF NEW DIRECTORS

VANCOUVER, BC, July 29, 2022 /CNW/ - LITE ACCESS TECHNOLOGIES INC. ("Lite Access") (TSXV: LTE) (OTC: LTCCF), a world leader in the fibre optic products and advanced installation methodologies, is pleased to announce the appointments of Mr. Alex McAulay and Mr. Mike Irmen to the Board of Directors.

Alexander McAulay, CPA, CA is an entrepreneur and experienced public company CFO and director. Mr. McAulay's firm, ACM Management Inc., provides fractional CFO and regulatory guidance to public companies. Alex has served as the CFO of several listed companies and has assisted dozens of issuers in navigating the public markets.

Mike Irmen has been the owner of Ironman Directional Drilling LTD for over 14 years.  Having greater than 30 years' experience in the industry as an experienced and knowledgeable civil contractor has resulted in the award of numerous projects throughout British Columbia, Alberta and Saskatchewan.  Providing an organized approach to all projects including attention to safety, Mike successfully achieves ways to increase efficiencies and reduce costs in each project.

Mike Plotnikoff, interim Chief Executive Officer of Lite Access, stated, "We are incredibly pleased to have Alex and Mike as part of the team at Lite Access.  Having a Board of Directors possessing industry knowledge in furtherance of the company's strategy will contribute to the growth and success going forward.  More importantly, each of the newly formed board and management team hold meaningful positions in Lite Access each contributing to the overall success of the Company and in the best interest of our shareholders."

The Company also announces that it has granted a total of 5,645,000 stock options to its directors, officers, and employees.  The options were granted at a price of $0.10 per share and are exercisable for a period of five years from the date of grant.

About Lite Access

Lite Access Technologies Inc. is a world leader in the use of innovative and proven micro/narrow trenching technologies, alternate methods of deployment and specialist products which transform the cost the network deployment for telecommunications operators.

As part of its suite of services Lite Access provides clients with integrated solutions or select components for the design and implementation of fibre optic networks.  Lite Access' products have been deployed in many high-profile communication networks including Olympic facilities, military and government, numerous communities throughout the United Kingdom, the USA and Canada as well as global telecommunications companies that have adopted Lite Access as the "solution of choice" for the least invasive, most cost effective and future-proof fibre optic connectivity available.

Lite Access' installation technology and proprietary products extend a network provider's ability to deliver true broadband connectivity directly to end-users, such as homes, businesses, government and educational institutions, and emergency response facilities. Lite Access remains flexible and innovative in its commitment to provide global clients and partners with the most cost effective and proven fibre connectivity solutions available.

Forward Looking Information
This news release contains statements that, to the extent they are not recitations of historical fact, may constitute "forward-looking statements" within the meaning of applicable Canadian securities laws. Lite Access uses words such as "may", "would", "could", "will", "likely", "expect", "believe", "intend" and similar expressions to identify forward-looking statements. Any such forward-looking statements are based on assumptions and analyses made by Lite Access in light of its experience and its perception of historical trends, current conditions and expected future developments. However, whether real results and developments will conform to Lite Access' expectations and predictions is subject to any number of risks, assumptions and uncertainties.  Many factors could cause Lite Access' real results to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors include, among other things: risks and uncertainties described in Lite Access's most exact Management Discussion & Analysis (MD&A) for the financial year ended September 30, 2021 which can be accessed at www.sedar.com. The "forward-looking statements" contained herein speak only as of the date of this press release and, unless required by applicable law, Lite Access undertakes no obligation to publicly update or revise such information, whether as a result of new information, future events or otherwise.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE Lite Access Technologies Inc

Cision

View original content: http://www.newswire.ca/en/releases/archive/July2022/29/c7288.html

Fri, 29 Jul 2022 10:22:00 -0500 en-US text/html https://finance.yahoo.com/news/lite-access-technologies-announces-appointment-220800304.html
Killexams : Effort tracking US school shootings loses federal funding weeks after Uvalde massacre

An effort to update one of the most comprehensive databases tracking school shootings nationwide is no longer receiving federal funding, according to the project’s top researcher, who says a private contractor recently decided not to renew his contract working on the database.  
 
The K-12 School Shooting Database has been widely cited by news organizations and featured in dozens of academic reports and studies, including numerous analyses of school safety by federal government agencies, including the Department of Justice, Department of Education and the Government Accountability Office. 
 
Since its inception four years ago, prompted by a high-profile school shooting in Parkland, Fla., the database had been supported by the federal Center for Homeland Defense and Security. 
 
But database co-founder David Riedman said a private company contracted by the federal center told him on June 30 that his contract with the company to work on the database, which expired that day, would not be renewed. 
 
Riedman said he believed political pressure played a role in that decision, which came weeks after the database received heightened press and public attention following a mass school shooting in Uvalde, Texas, in late May in which 19 children and two adults were killed – the second deadliest school shooting in U.S. history. 
 
Riedman said he's updated the database on his own over the past month on a separate website he’s funding himself, k12ssdb.org. He said he’s committed to continuing the project but plans to do so independently.

"I'm disappointed to see after four years for the project to go that direction after one of the worst school shootings in exact U.S. history," said Riedman. 
 
Lea Culver, president and CEO of the private contractor, Creek Technologies Inc., declined to comment on why Riedman’s contract was not renewed, saying the company "does not comment directly on (employment) and consultant issues." 
 
Creek Technologies, an Ohio-based company that specializes in information technology, educational services and management consulting, "continues to deliver high-quality services" to the federal center "and is not breaching its contractual obligations," Culver said. 
 
The Center for Homeland Defense and Security this month revised its website to say future updates to the database will be done by Riedman on the new, independent website he created and provided a link to Riedman’s website. 
 
The center said it plans to convert the data previously collected into a historical report that will be part of an upcoming “School Shooting Safety Compendium to aid officials and researchers on the topic.” Along with the report, “the new Compendium website will include data, research links, recommended policies, procedures, and resources related to school safety and preventing violence in schools,” the center’s website said. 
 
Ed Early, a spokesman for the U.S. Navy’s Naval Postgraduate School based in Monterey, Calif., which operates the Center for Homeland Defense and Security, said in a statement: “Neither CHDS nor NPS was or is a party to financial or employment negotiations between Creek Technologies and its subcontractor. Within federal regulations and guidelines, the contractor can pursue different paths and options to meet the government’s requirements to include employment of sub-contractors or not.” 
 
“Regardless of any changes behind the scenes, what is important is that CHDS remains committed to supporting the K-12 School Shooting Database project and ensuring that this valuable resource continues to inform policymakers on possible solutions to these extraordinarily tragic events,” the statement added. “As part of this effort, CHDS has taken measures to maintain the historical database record on the CHDS website as a definitive, reliable resource for CHDS students, researchers and the public.” 
 
While some other federal and privately run databases track gun violence nationwide, the K-12 School Shooting Database stands out in several ways. 
 
"It's very, very valuable," said Justin Heinze, an educational psychology professor at the University of Michigan who has used the database. "What I like a lot about this database is the granularity." 
 
The definition for what types of incidents the database captures is broad. Riedman said the purpose is to not just account for high-profile mass shooting events, but also systemic gun violence incidents that can go overlooked and have been shown to disproportionately impact students of color and students from low-income families. According to the database, it "documents when a gun is brandished, is fired, or a bullet hits school property for any reason, regardless of the number of victims, time, or day of the week." 
 
There are more than 2,070 incidents recorded in the database, from a shooting Monday near a New York City high school that wounded a 16-year-old boy and a 12-year-old girl to the nation’s deadliest school shooting on record – the 2012 massacre at Sandy Hook Elementary School in which 20 children and 6 adults were killed. 
 
The data dates to 1970 – far longer than many other gun violence data sources – and it updates daily, whereas government data on mass shootings can lag by months or years. 

The database features uniquely rich details about each incident, such as describing where on school grounds the shooting occurred, what else was happening at the school at the time, and how the incident ended, which can be valuable for trying to understand trends and patterns around school gun violence, experts said. All the raw data, as well as details about the methodology researchers use to collect it, are available to anyone online. 
 
Heinze said if the project were to stop updating, it would be "a deficit to the research community." 
 
He said that's particularly the case because little research into gun violence was done from the mid-1990s, after the National Rifle Association successfully lobbied Congress to implement a de-facto ban on using federal funding for such research, until 2019, when Congress began allocating federal money to study gun violence – $25 million a year to the Centers for Disease Control and Prevention and the National Institutes of Health. 
 
"We are at a pivotal turning point where you are starting to see the federal government invest a lot of resources into gun violence prevention," said Heinze, who co-directs the National Center for School Safety and is an affiliate of the Institute for Firearm Injury Prevention. 
 
Kelly Drane, research director at the Giffords Law Center to Prevent Gun Violence, said there should be a greater investment of federal dollars to track school shootings and such work should not be viewed as controversial. 
 
“The federal government should be interested in tracking gun violence at schools and presenting that data to the public,” said Drane. “Every American should want to know how many times guns are being fired at schools regardless of what you think the solutions are.”  
 
At the time of the 2018 shooting in Parkland, Fla., which left 17 people dead and 17 injured, Riedman said he was enrolled in a Naval Postgraduate School program designed to incubate solutions for emerging homeland security issues.

“After Parkland, there were a number of warning signs, and those were missed because people didn't realize they were warning signs,” Riedman said.

He and another classmate initially envisioned creating a resource for teachers and school administrators to look out for, and act upon, potential warning signs.

To develop that, “We wanted to look at as many prior school shootings as we could to see how many they could stop,” Riedman said. "But we just couldn't find any good data."

Instead, he and the classmate began to build a database of their own, which became the K-12 School Shooting Database. The first iteration was published in September 2018.
 
Since December 2018, Riedman said he has been the lone researcher who has updated the database. 

Riedman said the project expanded and got a boost in resources during 2020 after the pandemic freed up money that would have otherwise been spent on travel. Updates included getting help to revamp the webpage hosting the data and building new ways to present the data using maps and graphics. 

Riedman said he hopes to keep improving the database through new partnerships with researchers and academic institutions. 
 
"This information has a ton of power to inform public policy and prevent another attack," Riedman said. 
 
He's focused on keeping the project "independent, nonpartisan and very transparent." 
 
While it wasn’t something he envisioned for the project a few weeks ago, he sees its newfound independence as a silver lining to his exact ordeal. 
 
“There are advantages to being involved with an official center and also disadvantages in terms of the amount of autonomy and how quickly you can make changes,” he said. Now, “there are a lot of opportunities to collaborate with people I otherwise wouldn’t have been able to collaborate with before.” 
 
“Ironically,” Riedman said, “this has highlighted the importance of this being an independent project.” 

Fri, 29 Jul 2022 07:49:00 -0500 en-US text/html https://www.stamfordadvocate.com/news/article/school-shootings-database-loses-federal-funding-17337968.php?t=1ea3ca885f&src=sthplocal Killexams : PureTech Founded Entity Akili Announces Phase 3 Study of Digital Treatment in Children with ADHD Begun by Shionogi in Japan

BOSTON--(BUSINESS WIRE)--Aug 1, 2022--

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company noted that its Founded Entity, Akili Interactive Labs, Inc. (“Akili”), a leading digital medicine company, today announced the start of a pivotal Phase 3 randomized, controlled study of SDT-001 (a version of AKL-T01 localized for Japanese language and culture), a product candidate designed to Strengthen measures of attention in children diagnosed with attention-deficit/hyperactivity disorder (“ADHD”). The study, conducted by Akili’s partner, global pharmaceutical company Shionogi & Co., Ltd. (“Shionogi”), is designed to evaluate the safety and efficacy of the product candidate in children ages 6-17 with ADHD as a registration-enabling trial. Clinical trial sites have begun enrolling patients, and results of the study are expected in 2H2023.

This study represents the first pivotal study of Akili’s video game-based cognitive treatment outside of the U.S. SDT-001 was developed specifically for use in the Japanese market, adapting Akili’s AKL-T01 for Japanese language and culture. The disease agnostic proprietary technology is designed to treat impaired cognitive function, specifically attention control. Delivered through an action video game experience, this innovative technology presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function while using adaptive algorithms to personalize the treatment experience for each individual patient.

The pivotal study of SDT-001 is being conducted across multiple sites in Japan and is expected to enroll approximately 150 children ages 6-17 years diagnosed with ADHD. The study design was informed by Shionogi’s successful Phase 2 study of SDT-001.

Branded and marketed as EndeavorRx ® in the U.S., AKL-T01 is cleared for use by the U.S. Food and Drug Administration (FDA) and has received Conformité Européenne (CE) Mark certification in Europe for use in attention and inhibitory control deficits in pediatric ADHD. Please see below for full indication and safety information.

The full text of the announcement from Akili is as follows:

Shionogi Begins Phase 3 Study in Japan of Akili’s Digital Treatment in Children with ADHD

Pivotal study follows successful Phase 2 trial, which demonstrated improvements in attention function as compared to both treatment as usual and single task video game groups.

Pivotal Data Readout expected in 2H2023

BOSTON, Mass. – August 1, 2022 – Akili Interactive (“Akili”), a leading digital medicine company, today announced the start of a pivotal Phase 3 randomized, controlled study of SDT-001 (a version of AKL-T01 localized for Japanese language and culture), a product candidate designed to Strengthen measures of attention in children diagnosed with attention-deficit/hyperactivity disorder (“ADHD”). The study, conducted by Akili’s partner, global pharmaceutical company Shionogi & Co., Ltd. (“Shionogi”), is designed to evaluate the safety and efficacy of the product candidate in children ages 6-17 with ADHD as a registration-enabling trial. Clinical trial sites have begun enrolling patients, and results of the study are expected in 2H2023.

“ADHD has a significant impact on children and their families in Asia, and caregivers and health care providers are looking for innovative non-drug treatment options. Following our successful Phase 2 study of SDT-001, we are excited to advance Akili’s product candidate through the clinical process to potentially help the millions of children living in Japan with ADHD,” said Takeki Uehara, Corporate Officer, Senior Vice President, Drug Development and Regulatory Science Division of Shionogi & Co., Ltd.

“We are thankful to our partners at Shionogi who share our commitment to patients and have initiated this pivotal study ahead of schedule,” said Anil S. Jina M.D., Chief Medical Officer of Akili. “This trial is an important step towards our goal to help all eligible children with ADHD across the globe, irrespective of their language, culture, or geographic location.”

The pivotal study of SDT-001 is being conducted across multiple sites in Japan and is expected to enroll approximately 150 children ages 6-17 years diagnosed with ADHD. The study design was informed by Shionogi’s successful Phase 2 study of SDT-001. It consists of two parts, a comparison part and a repetition part.

  • Comparison part: Qualifying participants are randomized to either 1) receive SDT-001 in addition to treatment as usual (“TAU”), consisting of psychoeducation and environmental support, or 2) continue TAU.
  • Repetition part: After completing the comparison part, both groups receive SDT-001.

Participants who receive SDT-001 treatment use the digital intervention for approximately 25 minutes per day, seven days per week for a total of six weeks of treatment. Following treatment, participants’ attention function is assessed by physicians using the ADHD-RS-IV inattentive subscale, a commonly used scale in evaluating ADHD treatments, and compared to baseline.

This study represents the first pivotal study of Akili’s video game-based cognitive treatment outside of the U.S. SDT-001 was developed specifically for use in the Japanese market, adapting Akili’s AKL-T01 for Japanese language and culture. The disease agnostic proprietary technology is designed to treat impaired cognitive function, specifically attention control. Delivered through an action video game experience, this innovative technology presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function while using adaptive algorithms to personalize the treatment experience for each individual patient. AKL-T01 has been evaluated across five clinical studies in more than 600 children diagnosed with ADHD, including a prospective, randomized, controlled study published in The Lancet Digital Health. The technology is also being studied by Akili in multiple other indications with associated chronic and acute cognitive impairments, including autism spectrum disorder (“ASD”), multiple sclerosis, major depressive disorder, COVID-19 brain fog, cancer-related cognitive impairment and postoperative cognitive dysfunction. Branded and marketed as EndeavorRx Ⓡ in the U.S., AKL-T01 is cleared for use by the U.S. Food and Drug Administration (FDA) and has received Conformité Européenne (CE) Mark certification in Europe for use in attention and inhibitory control deficits in pediatric ADHD. Please see below for full indication and safety information.

In September 2021, Akili and Shionogi announced the results of a Phase 2 study of SDT-001 in Japan. The study enrolled a total of 261 children ages 6-17 years diagnosed with ADHD and evaluated their attention impairment using the ADHD RS-IV Inattention scale, comparing those who received the Akili treatment to those receiving TAU and those who received a control app (single task video game). The SDT-001 treatment group showed larger improvements across the clinical endpoints compared to both the TAU and the control app groups. In the total population, the improvements seen over the control app did not meet statistical significance, but post hoc analysis applying the propensity score suggested that SDT-001 improvements over TAU were statistically significant. SDT-001 was well-tolerated and there were no serious adverse events. Adverse events reported were consistent with previous clinical studies of the digital treatment. Adverse device reactions were reported in 4 patients (3.7%) treated with SDT-001 and were mild in severity including irritability, somnolence, tinnitus and nausea.

Akili and Shionogi formed a strategic partnership in May 2019 for the commercialization of Akili’s AKL-T01 and AKL-T02, as potential treatments of cognitive impairments in children with ADHD and ASD, respectively, in Japan and Taiwan. The partnership leverages each party’s distinct expertise to build a novel commercial model and seek to launch the new class of treatment to patients. Under the terms of the agreement, Shionogi has exclusive rights to the clinical development and is responsible for regulatory filings, sales and marketing of the technologies in Japan and Taiwan. Akili is responsible for building and maintaining R&D and commercial platforms designed specifically for digital therapeutics, including all global product development activities, distribution and technical support services. Akili maintains exclusive global rights to develop and commercialize AKL-T01 and AKL-T02 in all territories outside of Japan and Taiwan.

EndeavorRx ® Indication and Overview

EndeavorRx is the first prescription video game treatment granted marketing authorization by the FDA. In the U.S., EndeavorRx is indicated to Strengthen attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA ® ) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. The most common side effect observed in children in EndeavorRx’s clinical trial was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider.

About Akili

Akili is pioneering the development of cognitive treatments through game-changing technologies. Our approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences.

Additional Information and Where to Find It

In connection with the proposed business combination transaction between Social Capital Suvretta Holdings Corp. I (“SCS”) and Akili, SCS filed a registration statement on Form S-4 (as amended, the “Registration Statement”) with the SEC on February 14, 2022, which includes a document that serves as a prospectus and proxy statement of SCS, referred to as a proxy statement/prospectus. The Registration Statement became effective on July 21, 2022. SCS has mailed a definitive proxy statement/prospectus and other relevant documents to its shareholders of record as of July 14, 2022, the record date established for the extraordinary general meeting of SCS shareholders relating to the proposed transaction. The proxy statement/prospectus has been distributed to SCS’s shareholders in connection with SCS’s solicitation of proxies for the vote by SCS’s shareholders with respect to the proposed transaction. SCS may also file other documents regarding the proposed transaction with the SEC. BEFORE MAKING ANY VOTING DECISION, SHAREHOLDERS OF SCS ARE ADVISED TO READ THE REGISTRATION STATEMENT, THE PROXY STATEMENT/PROSPECTUS AND ALL OTHER RELEVANT DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Shareholders will be able to obtain free copies of the Registration Statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by SCS (when available) through the website maintained by the SEC at http://www.sec.gov.

The documents filed by SCS with the SEC also may be obtained free of charge at SCS’s website at https://socialcapitalsuvrettaholdings.com/dnaa or upon written request to 2850 W. Horizon Ridge Parkway, Suite 200, Henderson, NV 89052.

Participants in the Solicitation

SCS and Akili and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from SCS’s shareholders in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed transaction between Akili and SCS are contained in the proxy statement/prospectus. You may obtain free copies of these documents as described in the preceding paragraph.

No Offer or Solicitation

This communication shall not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction. This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act or an exemption therefrom. This press release may be deemed to be solicitation material in respect of the proposed transactions contemplated by the proposed business combination between Akili and SCS.

Forward-Looking Statements

This communication may contain certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding Akili’s expectations for EndeavorRx® and digital medicine, the development of its platform and the launch of EndeavorRx ®, its partnership with Shionogi and the benefits expected therefrom, including the timing and results expected from its pivotal Phase 3 trial of SDT-001. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause real future events to differ materially from the forward-looking statements in this communication, including but not limited to (i) the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect the price of SCS’s securities, (ii) the risk that the proposed transaction may not be completed by SCS’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by SCS, (iii) the failure to satisfy the conditions to the consummation of the proposed transaction, including the adoption of the Merger Agreement by the shareholders of SCS and the satisfaction of the minimum cash condition, (iv) the lack of a third party valuation in determining whether or not to pursue the proposed transaction, (v) the inability to complete the PIPE Investment, (vi) the occurrence of any event, change or other circumstance that could deliver rise to the termination of the Merger Agreement, (vii) the effect of the announcement or pendency of the transaction on Akili’s business relationships, operating results, and business generally, (viii) risks that the proposed transaction disrupts current plans and operations of Akili or diverts management’s attention from Akili’s ongoing business operations and potential difficulties in Akili employee retention as a result of the announcement and consummation of the proposed transaction, (ix) the outcome of any legal proceedings that may be instituted against Akili or against SCS related to the Merger Agreement or the proposed transaction, (x) the ability to maintain the listing of SCS’s securities on a national securities exchange, (xi) the price of SCS’s securities may be volatile due to a variety of factors, including changes in the competitive and highly regulated industries in which SCS plans to operate or Akili operates, variations in operating performance across competitors, changes in laws and regulations affecting SCS’s or Akili’s business, and changes in the combined capital structure, (xii) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed transaction, and identify and realize additional opportunities, (xiii) the ability of Akili to successfully commercialize EndeavorRx ® and continue to advance its clinical development pipeline, (xiv) the ability to recognize the anticipated benefits of the proposed transaction, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its management and key employees, (xv) the evolution of the markets in which Akili competes, (xvi) the ability of Akili to defend its intellectual property and satisfy regulatory requirements, (xvii) the costs related to the proposed transaction, (xviii) the impact of the COVID-19 pandemic on Akili’s business, (xix) Akili’s expectations regarding its market opportunities, (xx) the risk of downturns and a changing regulatory landscape in the highly competitive industry in which Akili operates and (xxi) the timing and results expected from Akili and its partners' clinical trials. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of SCS’s registration on Form S-1 (File Nos. 333-256723 and 333-257543), SCS’s quarterly report on Form 10-Q for the quarter ended March 31, 2022 filed with the SEC on May 16, 2022, the Registration Statement, including those under “Risk Factors” therein, and other documents filed by SCS from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause real events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Akili and SCS assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Neither Akili nor SCS gives any assurance that either Akili or SCS, or the combined company, will achieve its expectations.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including inflammatory, fibrotic and immunological conditions, intractable cancers, lymphatic and gastrointestinal diseases and neurological and neuropsychological disorders, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech's Founded Entities, is comprised of 27 therapeutics and therapeutic candidates, including two that have received both U.S. FDA clearance and European marketing authorization, as of the date of PureTech's most recently filed Annual Report and corresponding Form 6-K. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on unique insights in immunology and drug development.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those statements that relate to the Phase 3 study of Akili’s SDT-001 to be conducted by Shionogi and expectations related to the timing of results from the study, Akili’s proposed business combination transaction with Social Capital Suvretta Holdings Corp. I, and Akili’s and PureTech's future prospects, development plans, and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause real results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2021 filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com:https://www.businesswire.com/news/home/20220801005236/en/

CONTACT: PureTech

Public Relations

publicrelations@puretechhealth.com

Investor Relations

IR@puretechhealth.comEU Media

Ben Atwell, Rob Winder

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SOURCE: PureTech Health plc

Copyright Business Wire 2022.

PUB: 08/01/2022 07:05 AM/DISC: 08/01/2022 07:06 AM

http://www.businesswire.com/news/home/20220801005236/en

Sun, 31 Jul 2022 23:28:00 -0500 en text/html https://www.joplinglobe.com/region/national_business/puretech-founded-entity-akili-announces-phase-3-study-of-digital-treatment-in-children-with-adhd/article_a8f980c0-7b16-5b5e-beaa-ca023b3c7a57.html
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