Author: Admin

Developer

New Data Suggest COVAXIN™ (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

Posted on by Admin



New Data Suggest COVAXIN™ (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

 

Research, News, and Market Data on Ocugen

 

  • Level of vaccine-induced spike and nucleoprotein antibodies titers demonstrated to be comparable to that following natural infection
  • Immune memory against conserved nucleoprotein may provide an added advantage over spike-only responses
  • Memory T and B cells persisted for at least 6 months post vaccination
  • Data suggest COVAXIN™ (BBV152) may provide protection against current and future variants
  • Effectiveness of COVAXIN™ (BBV152) against the Omicron variant is currently being studied

MALVERN, Pa., Dec. 15, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that data analyzing immune response following two doses of the vaccine candidate, COVAXIN™ (BBV152), from a third-party study were published on the preprint server, medRxiv. The data compared the immune memory response of 71 vaccinated and 73 naturally infected subjects with SARS-CoV-2, including variants of concern, for up to six months. The study found that COVAXIN™ (BBV152) generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells.  

In addition to controlling infections, the adaptive immune system creates immunological memory, such as memory B and T cells, to enable long-term protection against a virus. In the analysis, COVAXIN™ (BBV1542) generated T-cells against both spike and nucleocapsid proteins in nearly 85 percent of subjects that persisted for at least 6 months. This data supports previous findings that COVAXIN™ (BBV152) is able to induce long-term memory.

“As a whole-virion inactivated vaccine, we anticipated COVAXIN™ would produce an immune response against multiple antigens present in the SARS-CoV-2 virus, such as spike and nucleoprotein antibodies,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen.

“The results of this analysis are extremely important findings as we continue to learn about how the virus is mutating and how we can address variants of concern with vaccines, especially with the emergence of Omicron,” said David Fajgenbaum, MD, MBA, MSc, FCPP, Assistant Professor of Medicine in Translational Medicine & Human Genetics at the University of Pennsylvania and member of Ocugen’s Vaccine Scientific Advisory Board. “Given that current variants of concern exhibit mutations concentrated in the spike protein of the virus, vaccines like COVAXIN™ that can generate broad immune memory beyond the spike protein are a promising tool to protect us from emerging variants of concern.”  

Ocugen is currently evaluating COVAXIN™ (BBV152) against the Omicron variant and plans to share the data as soon as they are available.

Earlier this year, Ocugen’s co-development partner, Bharat Biotech, announced data from a Phase 3 trial that included nearly 25,800 participants. In the study, published in The Lancet, COVAXIN™ (BBV152) demonstrated 77.8% overall efficacy, 93.4% efficacy against severe illness (which requires hospitalization, intensive care and/or a ventilator) and 65.2% efficacy against the Delta variant. Adverse events reported in the trial were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events, which is consistent with data from other vaccines that apply whole-virion technology. Both adverse events and serious adverse events reported in the vaccine group were reported at similar rates to the placebo group.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 125 million doses having been administered to adults outside the U.S., COVAXIN™ is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™. The trade name COVAXIN™ has not been evaluated by the FDA.

About Ocugen, Inc. 
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. 

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com. 

Cautionary Note on Forward-Looking Statements  
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include statements about data published on the preprint server, medRxiv, which found that COVAXIN™ generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells, and our expectation that COVAXIN can generate potential long-term immunological memory. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the risk that the data published on medRxiv, which is preliminary and subject to ongoing peer review, may not be accepted for publication without changes, if at all, may contain errors that render the reported information erroneous, or may not be accepted by the scientific or medical community; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that inversely impact our ability to advance the development of COVAXIN™ in the United States, the implications that this clinical hold may have for our request for emergency use authorization for COVAXIN for pediatric use; commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether we will be able to provide the FDA with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA) or emergency use authorization (EUA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA, including our planned Phase 3 clinical trial which is currently subject to clinical hold; any additional chemistry, manufacturing and controls information that we may be required to submit to the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com 

Release – New Data Suggest COVAXIN (BBV152) Vaccine Candidate Generates Robust Immune Memory

Posted on by Admin



New Data Suggest COVAXIN™ (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

 

Research, News, and Market Data on Ocugen

 

  • Level of vaccine-induced spike and nucleoprotein antibodies titers demonstrated to be comparable to that following natural infection
  • Immune memory against conserved nucleoprotein may provide an added advantage over spike-only responses
  • Memory T and B cells persisted for at least 6 months post vaccination
  • Data suggest COVAXIN™ (BBV152) may provide protection against current and future variants
  • Effectiveness of COVAXIN™ (BBV152) against the Omicron variant is currently being studied

MALVERN, Pa., Dec. 15, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that data analyzing immune response following two doses of the vaccine candidate, COVAXIN™ (BBV152), from a third-party study were published on the preprint server, medRxiv. The data compared the immune memory response of 71 vaccinated and 73 naturally infected subjects with SARS-CoV-2, including variants of concern, for up to six months. The study found that COVAXIN™ (BBV152) generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells.  

In addition to controlling infections, the adaptive immune system creates immunological memory, such as memory B and T cells, to enable long-term protection against a virus. In the analysis, COVAXIN™ (BBV1542) generated T-cells against both spike and nucleocapsid proteins in nearly 85 percent of subjects that persisted for at least 6 months. This data supports previous findings that COVAXIN™ (BBV152) is able to induce long-term memory.

“As a whole-virion inactivated vaccine, we anticipated COVAXIN™ would produce an immune response against multiple antigens present in the SARS-CoV-2 virus, such as spike and nucleoprotein antibodies,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen.

“The results of this analysis are extremely important findings as we continue to learn about how the virus is mutating and how we can address variants of concern with vaccines, especially with the emergence of Omicron,” said David Fajgenbaum, MD, MBA, MSc, FCPP, Assistant Professor of Medicine in Translational Medicine & Human Genetics at the University of Pennsylvania and member of Ocugen’s Vaccine Scientific Advisory Board. “Given that current variants of concern exhibit mutations concentrated in the spike protein of the virus, vaccines like COVAXIN™ that can generate broad immune memory beyond the spike protein are a promising tool to protect us from emerging variants of concern.”  

Ocugen is currently evaluating COVAXIN™ (BBV152) against the Omicron variant and plans to share the data as soon as they are available.

Earlier this year, Ocugen’s co-development partner, Bharat Biotech, announced data from a Phase 3 trial that included nearly 25,800 participants. In the study, published in The Lancet, COVAXIN™ (BBV152) demonstrated 77.8% overall efficacy, 93.4% efficacy against severe illness (which requires hospitalization, intensive care and/or a ventilator) and 65.2% efficacy against the Delta variant. Adverse events reported in the trial were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events, which is consistent with data from other vaccines that apply whole-virion technology. Both adverse events and serious adverse events reported in the vaccine group were reported at similar rates to the placebo group.

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 125 million doses having been administered to adults outside the U.S., COVAXIN™ is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™. The trade name COVAXIN™ has not been evaluated by the FDA.

About Ocugen, Inc. 
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Bharat Biotech 
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. 

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com. 

Cautionary Note on Forward-Looking Statements  
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include statements about data published on the preprint server, medRxiv, which found that COVAXIN™ generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells, and our expectation that COVAXIN can generate potential long-term immunological memory. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the risk that the data published on medRxiv, which is preliminary and subject to ongoing peer review, may not be accepted for publication without changes, if at all, may contain errors that render the reported information erroneous, or may not be accepted by the scientific or medical community; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the FDA could make other decisions that inversely impact our ability to advance the development of COVAXIN™ in the United States, the implications that this clinical hold may have for our request for emergency use authorization for COVAXIN for pediatric use; commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether we will be able to provide the FDA with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA) or emergency use authorization (EUA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA, including our planned Phase 3 clinical trial which is currently subject to clinical hold; any additional chemistry, manufacturing and controls information that we may be required to submit to the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com 

Release – Seanergy to Present at the NobleCon Online Transportation Logistics Investor Forum

Posted on by Admin



Seanergy to Present at the NobleCon Online Transportation & Logistics Investor Forum

Research, News, and Market Data on Seanergy Maritime

 

December 15, 2021 – Glyfada, Greece – Seanergy Maritime Holdings Corp. (the “Company” or “Seanergy”) (NASDAQ: SHIP) announced today its participation at the Transportation & Logistics Virtual Investor Forum, presented by Channelchek.com.

Seanergy’s CEO, Stamatis Tsantanis, and CFO, Stavros Gyftakis, are giving a presentation of the Company, followed by a Q&A session moderated by Noble Capital Markets senior equity research analyst, Poe Fratt.

The broadcast is scheduled for December 16, 2021, at 11:00 AM EST and can be accessed by registering at www.channelchek.com at no cost. The video webcast will be later archived on Channelchek as part of its C-Suite Series www.channelchek.com/c-suite, and on its YouTube channel: www.youtube.com/channelchek .

About Seanergy Maritime Holdings Corp.

Seanergy Maritime Holdings Corp. is the only pure-play Capesize ship-owner publicly listed in the US. Seanergy provides marine dry bulk transportation services through a modern fleet of Capesize vessels. The Company’s operating fleet consists of 17 Capesize vessels with an average age of 11.7 years and aggregate cargo carrying capacity of approximately 3,011,083 dwt.

The Company is incorporated in the Marshall Islands and has executive offices in Glyfada, Greece. The Company’s common shares trade on the Nasdaq Capital Market under the symbol “SHIP” and its Class B warrants under “SHIPZ”.

Please visit our company website at: www.seanergymaritime.com.

About Noble Capital Markets, Inc.

Noble Capital Markets (“Noble”) is a research driven boutique investment bank that has supported small & microcap companies since 1984. As a FINRA and SEC licensed broker dealer Noble provides institutional-quality equity research, merchant and investment banking, wealth management and order execution services. In 2005, Noble established NobleCon, an investor conference that has grown substantially over the 16 years. In 2018 Noble launched www.channelchek.com – a new investment community dedicated exclusively to small and micro-cap companies and their industries. Channelchek is tailored to meet the needs of self-directed investors and financial professionals. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 emerging growth companies are listed on the site, with growing content including the C-Suite and Virtual Roadshow Series videos, and balanced news.

About Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. www.channelchek.com email: contact@channelchek.com .

Forward-Looking Statements

This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “should”, “expects”, “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company’s operating or financial results; the Company’s liquidity, including its ability to service its indebtedness; competitive factors in the market in which the Company operates; shipping industry trends, including charter rates, vessel values and factors affecting vessel supply and demand; future, pending or recent acquisitions and dispositions, business strategy, areas of possible expansion or contraction, and expected capital spending or operating expenses; risks associated with operations outside the United States; risks associated with the length and severity of the ongoing novel coronavirus (COVID-19) outbreak, including its effects on demand for dry bulk products and the transportation thereof; and other factors listed from time to time in the Company’s filings with the SEC, including its most recent annual report on Form 20-F. The Company’s filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information please contact:

Seanergy Investor Relations
Tel: +30 213 0181 522
E-mail: ir@seanergy.gr

Capital Link, Inc.
Paul Lampoutis
230 Park Avenue Suite 1536
New York, NY 10169
Tel: (212) 661-7566
E-mail: seanergy@capitallink.com

QuickChek – December 15, 2021

Posted on by Admin



Eagle Bulk Shipping Inc. to Present at Noble’s Virtual Transportation & Logistics Investor Forum

Eagle Bulk Shipping announced that its CEO, Gary Vogel, will present at Noble Capital Markets’ Virtual Transportation & Logistics Forum which is to be held on December 16, 2021 at 09:00 EST

Research, News & Market Data on Eagle Bulk Shipping

Watch recent presentation from Eagle Bulk Shipping



Seanergy to Present at the NobleCon Online Transportation & Logistics Investor Forum

Seanergy Maritime Holdings announced its participation at the Transportation & Logistics Virtual Investor Forum, presented by Channelchek.com

More info on the Transportation & Logistics Forum

Research, News & Market Data on Seanergy Maritime

Watch recent presentation from Seanergy Maritime



Energy Fuels Announces Strategic Venture with Nanoscale Powders to Develop Innovative Rare Earth Metal-Making Technology

Energy Fuels announced the execution of a Memorandum of Understanding with Nanoscale Powders LLC for the development of a novel technology for the production of rare earth element metals

Research, News & Market Data on Energy Fuels

Watch recent presentation from Energy Fuels



New Data Suggest COVAXIN™ (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

Ocugen, Inc. announced that data analyzing immune response following two doses of the vaccine candidate, COVAXIN™ (BBV152), from a third-party study were published on the preprint server, medRxiv

Research, News & Market Data on Ocugen

Watch recent presentation from Ocugen

 

Stay up to date. Follow us:

 

Coeur Mining (CDE) – Exploration Activities Offer a Gold Lining

Posted on by Admin

Wednesday, December 15, 2021

Coeur Mining (CDE)
Exploration Activities Offer a Gold Lining

Coeur Mining Inc is a metals producer focused on mining precious minerals in the Americas. It is involved in the discovery and mining of gold and silver and generates the vast majority of revenue from the sale of these precious metals. The operating mines of the company are palmarejo, rochester, wharf, and kensington. Its projects are located in the United States, Canada and Mexico, and North America.

Mark Reichman, Senior Research Analyst of Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

    Exploration update. Coeur provided an update on its exploration activities at Rochester in northern Nevada and the Crown properties in southern Nevada. Through October 2021, Coeur drilled 307,925 meters at six different locations and expects full year exploration expenditures of $65 million to $75 million. In late 2021, the company turned its attention to West Rochester, specifically the Gold Ridge and Lincoln Hill zones which could be a source of future higher-grade gold resources and to provide greater optionality for processing material from the larger Rochester district. The West Rochester property includes Lincoln Hill, Independence Hill, and Gold Ridge, and is west of infrastructure under construction as part of the Rochester expansion.

    Expanding the scope at Rochester.  Mapping, sampling, and geophysical surveys supported a focused drilling program over a much larger area at Rochester than undertaken previously. Through October, Coeur drilled 74 holes in the Rochester pit and NV Packard areas. Two rigs recently began drilling at Lincoln Hill and Gold Ridge. In early 2022, Coeur expects to receive approval for a 250-acre drilling …



This research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Release – Energy Fuels Announces Strategic Venture with Nanoscale Powders to Develop Innovative Rare Earth Metal-Making Technology

Posted on by Admin

 

 


Energy Fuels Announces Strategic Venture with Nanoscale Powders to Develop Innovative Rare Earth Metal-Making Technology

 

Nanoscale’s patented rare earth metal-making technology has potential to revolutionize rare earth metal making by reducing costs, significantly reducing greenhouse gas emissions, and reducing energy use

LAKEWOOD, Colo., Dec. 15, 2021 /CNW/ – Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) (“Energy Fuels” or the “Company”) is pleased to announce the execution of a Memorandum of Understanding (“MOU”) with Nanoscale Powders LLC (“NSP”) for the development of a novel technology (the “Technology“) for the production of rare earth element (“REE”) metals (the “Project“). We believe this Technology, which was initially developed by NSP, and will be advanced by the Company and NSP working together, has the potential to revolutionize the rare earth metal making industry by reducing costs of production, reducing energy consumption, and significantly reducing greenhouse gas (“GHG”) emissions. Producing REE metals and alloys (“REE Metals”) is a key step in a fully integrated REE supply chain, after production of separated REE oxides (“REE Oxides”) and before the manufacture of neodymium iron boron (“NdFeB”) magnets used in electric vehicles (“EVs“), wind generation and other clean energy and advanced technologies.

Energy Fuels is quickly building a new, environmentally friendly REE supply chain in the United States, and the Project with NSP represents an exciting opportunity to significantly improve the REE metal-making process and potentially provide Energy Fuels with a competitive advantage in the REE supply chain. At its White Mesa Mill (the “Mill“) in Utah, the Company is currently producing mixed REE carbonate (“REE Carbonate”) while recovering uranium from natural monazite sands (“Monazite”) which are produced as a low-cost byproduct of heavy mineral sands mining in the U.S. and around the globe. Energy Fuels’ REE Carbonate is the most advanced REE product being produced in the U.S. today. The Company is also moving quickly toward producing REE Oxides at the Mill using proven solvent extraction (“SX”) technologies. The Mill has over 40 years of experience producing uranium and vanadium oxides using SX technology.

Founded in 2008, NSP originally focused on producing solar quality silicon metals and refractory metal powders, eventually turning its attention to the production of titanium and alloy powders through sodium reduction. More recently, NSP has developed a process to create REE Metals from REE Oxides through molten sodium reduction of anhydrous REE chloride materials in a process similar to the Kroll process (called the “Hunter Titanium Process”) which is used for the production of titanium metals through sodium reduction.

The production of REE Metals utilizing the Technology will involve feeding anhydrous REE chloride materials, which are free of water, into a molten sodium bath. A rapid reaction takes place between the molten sodium and the REE chlorides. The process is highly exothermic, releasing energy, so the molten sodium acts to control the rate of the reaction. The reaction products are REE Metal and sodium chloride, commonly known as salt.

The NSP sodium reduction of REE Metals has several advantages over the industry standard REE metal making method, which utilizes electrolytic reduction of REE oxides in molten lithium fluoride/REE fluoride baths. First, the NSP process does not have any associated air emissions, and therefore presents a significant improvement over the current technology, which emits carbofluoromethane (CF4) gas, which is a powerful GHG. Second, current estimates indicate that the NSP process is significantly cheaper to operate than the conventional electrolytic methods, because it does not consume graphite crucible materials and utilizes significantly less energy and labor. Finally, the NSP process requires anhydrous chloride feeds, which we believe can be generated directly from rich liquor streams coming from the Mill’s planned SX circuit. This could eliminate the need for oxalate precipitation and calcination of materials destined for REE metal making. As a result of these factors, operating cost savings are currently estimated to potentially be several times less than conventional REE metal-making methods.

As with any new technology, risks are present which must be evaluated and addressed, including successfully creating anhydrous chloride feeds at a commercial scale with the associated risk of elevated levels of oxygen in the final product, and the risk of being able to successfully remove and consolidate final REE Metal products.

NSP holds two U.S. patents and one pending patent application for the Technology, under which it has proven the ability to produce REE Metals on a kilogram batch scale basis at the U.S. Department of Energy’s Technology Readiness Level (“TRL”) 5. Energy Fuels’ initial investment in the Project is intended to advance the Technology to allow for: (i) the continuous, pilot-scale production of 10 kilograms per hour of neodymium-praseodymium (“NdPr”) metal that meets typical specifications for NdFeB magnets at TLR Level 7; (ii) the separate build of a batch reactor able to produce key minor magnet metals (e.g., dysprosium, terbium); and (iii) the demonstration of samarium-cobalt alloy production. The Project will be directed by Energy Fuels with technical support from other research firms and institutions as required.

Under the MOU, the parties will negotiate and enter into binding agreements (“Definitive Agreements”) that govern the Project, including the creation of a new entity that will hold an exclusive license to the Technology as it relates to REE Metal making. The MOU contemplates a phased development of the Project to scale-up to the production of 1,000 metric tonnes of one or more REE Metals per year. Energy Fuels will have the right to earn up to a 100% interest in the entity and Technology, as it relates to REE Metal making, by making the following capital investments:

  1. US$250,000 within five (5) business days after execution of the MOU;
  2. US$250,000 within five (5) business days after execution and delivery of the Definitive Agreements;
  3. US$1 million within five (5) business days after execution and delivery of the Definitive Agreements to be applied to the Project’s 2022 budget and work plan; and
  4. Energy Fuels will fund all future approved annual budgets as may be required for commercialization of the Project, up to a maximum additional expenditure of US$8.5 million over three (3) years, totaling US$10 million for the Project.

Upon the successful completion of the Project and the $10 million investment, Energy Fuels will control the exclusive rights to the entity and the Technology as it relates to REE Metal making. Energy Fuels will also have the right to cease funding at various decision points during the Project, at which point Energy Fuels will hold a percentage of the new entity and Technology, proportional to its amount contributed. If Energy Fuels ceases funding prior to earning 100% of the Technology, NSP will have the right in certain circumstances to acquire Energy Fuels’ interest in the entity and Technology by reimbursing Energy Fuels for its expenditures on the Project.

Mark S. Chalmers, President and CEO of Energy Fuels stated: “Metal-making is a critical step in the rare earth supply chain. Energy Fuels has already restored monazite ‘crack-and-leach’ capabilities to the U.S. at our White Mesa Mill in Utah, where today we are producing a high-purity mixed rare earth carbonate, which is ready for separation. No other company in the U.S. is currently producing a high-purity REE product ready for separation at commercial levels. We are also quickly moving toward adding solvent extraction separation equipment at the Mill and associated permitting that will allow us to produce commercial separated rare earth oxide powders in the coming years. In fact, we are already well advanced with piloting these capabilities on a continuous 24/7 basis at the Mill today.

“The next step in rare earth processing and refining is turning those separated rare earth oxide powders into usable rare earth metals and alloys, particularly NdPr metal needed for NdFeB magnets used in EVs, wind generation and other technologies. We are interested in Nanoscale Powders’ technology because we believe it has the potential to produce REE metals at lower cost, using less energy, and producing significantly less greenhouse gas emissions than conventional REE metal making methods. If successful, Nanoscale’s metal-making technology could be orders of magnitude safer and less expensive than the current established technology. This is the type of technology we as Americans need to develop to produce advanced rare earth materials in a cost-competitive manner, while achieving the highest standards of protection of public health, safety, and the environment. Nanoscale Powders has proven their technology on a small scale, and we look forward to working with them to advance the technology to pilot scale, and then to commercial scale in the coming years. Our relationship with Nanoscale Powders demonstrates Energy Fuels’ commitment to fully integrating a domestic REE processing supply chain in the most optimal and environmentally prudent manner possible.”

Implementation of this initiative is subject to the execution of Definitive Agreements.

ABOUT ENERGY FUELS

Energy Fuels is a leading U.S.-based uranium mining company, supplying U3O8 to major nuclear utilities. Energy Fuels also produces vanadium from certain of its projects, as market conditions warrant, and is ramping up to commercial-scale production of REE carbonate. Its corporate offices are in Lakewood, Colorado, near Denver, and all of its assets and employees are in the United States. Energy Fuels holds three of America’s key uranium production centers: the White Mesa Mill in Utah, the Nichols Ranch in-situ recovery (“ISR“) Project in Wyoming, and the Alta Mesa ISR Project in Texas. The White Mesa Mill is the only conventional uranium mill operating in the U.S. today, has a licensed capacity of over 8 million pounds of U3O8 per year, has the ability to produce vanadium when market conditions warrant, as well as REE carbonate from various uranium-bearing ores. The Nichols Ranch ISR Project is on standby and has a licensed capacity of 2 million pounds of U3O8 per year. The Alta Mesa ISR Project is also on standby and has a licensed capacity of 1.5 million pounds of U3O8 per year. In addition to the above production facilities, Energy Fuels also has one of the largest NI 43-101 compliant uranium resource portfolios in the U.S. and several uranium and uranium/vanadium mining projects on standby and in various stages of permitting and development. The primary trading market for Energy Fuels’ common shares is the NYSE American under the trading symbol “UUUU,” and the Company’s common shares are also listed on the Toronto Stock Exchange under the trading symbol “EFR.” Energy Fuels’ website is www.energyfuels.com.

ABOUT NANOSCALE

Nanoscale Powders LLC (www.nanoscalepowders.com) is a Boston-based, privately held company, operating patented processes capable of producing a wide range of engineered metal, alloy and ceramic powders and powder-derived products, including solids as well as additive-manufacturing powders. For further information, please contact Andrew.matheson@nanoscalepowders.com.

CAUTIONARY STATEMENTS REGARDING FORWARD LOOKING STATEMENTS

This news release contains “forward-looking information” within the meaning of applicable securities laws in the United States and Canada. Forward-looking information may relate to future events or future performance of Energy Fuels. All statements in this release, other than statements of historical facts, with respect to Energy Fuels’ objectives and goals, as well as statements with respect to its beliefs, plans, objectives, expectations, anticipations, estimates, and intentions, are forward-looking information. Specific forward-looking statements in this discussion include, but are not limited to, the following: any expectation that the Project will be successful; any expectation that the Project has the potential to revolutionize the rare earth metal making industry by reducing costs of production, reducing energy consumption and significantly reducing greenhouse gas emissions; any expectation that Energy Fuels will be successful in integrating a domestic REE processing supply chain in the most optimal and environmentally prudent manner possible or at all; any expectation that Energy Fuels will move quickly toward producing separated REE Oxides at the Mill using proven SX technologies or at all; any expectation that the Technology is a superior technology for the production of REE Metals; any expectation that application of the Technology does not result in any associated air emissions and therefore presents a significant improvement over the current technology; any expectation that the Technology is significantly cheaper to operate than the conventional electrolytic methods or that operating cost savings are potentially several times less than conventional methods; any expectation that Energy Fuels’ initial investment in the Project will advance the Technology to allow for the continuous, pilot-scale, production of 10 kilograms per hour of NdPr metal that meets typical specifications for NdFeB magnets at TLR Level 7 or that the other objectives of the Project will be achieved; any expectation that the parties will successfully negotiate and enter into binding Definitive Agreements such that the Project will proceed past the MOU stage; any expectation that Energy Fuels will earn a 100% interest in the Technology as it relates to REE Metal making; and any expectation that the Technology will be advanced to commercial scale in the coming years. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates” or “believes”, or variations of, or the negatives of, such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved. This information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements include risks associated with: technical difficulties; processing difficulties and upsets; the risk of elevated levels of oxygen in the final product; the risk of being able to successfully remove and consolidate final REE Metal products; licensing, permitting and regulatory delays; litigation risks; competition from others; and market factors, including future demand for and prices realized from the sale of REEs and REE Metals. Forward-looking statements contained herein are made as of the date of this news release, and Energy Fuels disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management’s estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. Energy Fuels assumes no obligation to update the information in this communication, except as otherwise required by law.

SOURCE Energy Fuels Inc.

For further information: ENERGY FUELS, Curtis Moore – VP of Marketing & Corporate Development, (303) 974-2154; cmoore@energyfuels.com

Release – Eagle Bulk Shipping Inc. to Present at Nobles Virtual Transportation Logistics Investor Forum

Posted on by Admin



Eagle Bulk Shipping Inc. to Present at Noble’s Virtual Transportation & Logistics Investor Forum

Research, News, and Market Data on Eagle Bulk Shipping

 

STAMFORD, Conn., 
Dec. 15, 2021 (GLOBE NEWSWIRE) — 
Eagle Bulk Shipping Inc. (Nasdaq: EGLE) (“Eagle Bulk”, “Eagle”, or the “Company”), one of the world’s largest owner-operators within the midsize drybulk segment, today announced that its CEO,  Gary Vogel, will present at Noble Capital Markets’ 
Virtual Transportation & Logistics Forum which is to be held on 
December 16, 2021 at 
09:00 EST. The presentation will be followed by a Q&A session moderated by 
Noble Capital Markets senior equity research analyst,  Poe Fratt.

A live webcast of the presentation can be accessed at Channelchek (http://www.channelchek.com), the investor portal created by Noble. The webcast will later be archived on Channelchek as part of Noble’s C-Suite Series (www.channelchek.com/c-suite)

About Eagle Bulk Shipping Inc.

Eagle Bulk Shipping Inc. (“Eagle” or the “Company”) is a US-based fully integrated shipowner-operator providing global transportation solutions to a diverse group of customers including miners, producers, traders, and end users. Headquartered in 
Stamford, Connecticut, with offices in 
Singapore and 
Copenhagen, Eagle focuses exclusively on the versatile midsize drybulk vessel segment and owns one of the largest fleets of Supramax / Ultramax vessels in the world. The Company performs all management services in-house (including: strategic, commercial, operational, technical, and administrative) and employs an active management approach to fleet trading with the objective of optimizing revenue performance and maximizing earnings on a risk-managed basis. For further information, please visit our website: www.eagleships.com.

Company Contact

Eagle Bulk Shipping Inc.
investor@eagleships.com
+1 203 276 8100

Media Contact

Rose & Company
+1 212 359 2228

Source: 
Eagle Bulk Shipping Inc.

Energy Fuels Announces Strategic Venture with Nanoscale Powders to Develop Innovative Rare Earth Metal-Making Technology

Posted on by Admin

 

 


Energy Fuels Announces Strategic Venture with Nanoscale Powders to Develop Innovative Rare Earth Metal-Making Technology

 

Nanoscale’s patented rare earth metal-making technology has potential to revolutionize rare earth metal making by reducing costs, significantly reducing greenhouse gas emissions, and reducing energy use

LAKEWOOD, Colo., Dec. 15, 2021 /CNW/ – Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) (“Energy Fuels” or the “Company”) is pleased to announce the execution of a Memorandum of Understanding (“MOU”) with Nanoscale Powders LLC (“NSP”) for the development of a novel technology (the “Technology“) for the production of rare earth element (“REE”) metals (the “Project“). We believe this Technology, which was initially developed by NSP, and will be advanced by the Company and NSP working together, has the potential to revolutionize the rare earth metal making industry by reducing costs of production, reducing energy consumption, and significantly reducing greenhouse gas (“GHG”) emissions. Producing REE metals and alloys (“REE Metals”) is a key step in a fully integrated REE supply chain, after production of separated REE oxides (“REE Oxides”) and before the manufacture of neodymium iron boron (“NdFeB”) magnets used in electric vehicles (“EVs“), wind generation and other clean energy and advanced technologies.

Energy Fuels is quickly building a new, environmentally friendly REE supply chain in the United States, and the Project with NSP represents an exciting opportunity to significantly improve the REE metal-making process and potentially provide Energy Fuels with a competitive advantage in the REE supply chain. At its White Mesa Mill (the “Mill“) in Utah, the Company is currently producing mixed REE carbonate (“REE Carbonate”) while recovering uranium from natural monazite sands (“Monazite”) which are produced as a low-cost byproduct of heavy mineral sands mining in the U.S. and around the globe. Energy Fuels’ REE Carbonate is the most advanced REE product being produced in the U.S. today. The Company is also moving quickly toward producing REE Oxides at the Mill using proven solvent extraction (“SX”) technologies. The Mill has over 40 years of experience producing uranium and vanadium oxides using SX technology.

Founded in 2008, NSP originally focused on producing solar quality silicon metals and refractory metal powders, eventually turning its attention to the production of titanium and alloy powders through sodium reduction. More recently, NSP has developed a process to create REE Metals from REE Oxides through molten sodium reduction of anhydrous REE chloride materials in a process similar to the Kroll process (called the “Hunter Titanium Process”) which is used for the production of titanium metals through sodium reduction.

The production of REE Metals utilizing the Technology will involve feeding anhydrous REE chloride materials, which are free of water, into a molten sodium bath. A rapid reaction takes place between the molten sodium and the REE chlorides. The process is highly exothermic, releasing energy, so the molten sodium acts to control the rate of the reaction. The reaction products are REE Metal and sodium chloride, commonly known as salt.

The NSP sodium reduction of REE Metals has several advantages over the industry standard REE metal making method, which utilizes electrolytic reduction of REE oxides in molten lithium fluoride/REE fluoride baths. First, the NSP process does not have any associated air emissions, and therefore presents a significant improvement over the current technology, which emits carbofluoromethane (CF4) gas, which is a powerful GHG. Second, current estimates indicate that the NSP process is significantly cheaper to operate than the conventional electrolytic methods, because it does not consume graphite crucible materials and utilizes significantly less energy and labor. Finally, the NSP process requires anhydrous chloride feeds, which we believe can be generated directly from rich liquor streams coming from the Mill’s planned SX circuit. This could eliminate the need for oxalate precipitation and calcination of materials destined for REE metal making. As a result of these factors, operating cost savings are currently estimated to potentially be several times less than conventional REE metal-making methods.

As with any new technology, risks are present which must be evaluated and addressed, including successfully creating anhydrous chloride feeds at a commercial scale with the associated risk of elevated levels of oxygen in the final product, and the risk of being able to successfully remove and consolidate final REE Metal products.

NSP holds two U.S. patents and one pending patent application for the Technology, under which it has proven the ability to produce REE Metals on a kilogram batch scale basis at the U.S. Department of Energy’s Technology Readiness Level (“TRL”) 5. Energy Fuels’ initial investment in the Project is intended to advance the Technology to allow for: (i) the continuous, pilot-scale production of 10 kilograms per hour of neodymium-praseodymium (“NdPr”) metal that meets typical specifications for NdFeB magnets at TLR Level 7; (ii) the separate build of a batch reactor able to produce key minor magnet metals (e.g., dysprosium, terbium); and (iii) the demonstration of samarium-cobalt alloy production. The Project will be directed by Energy Fuels with technical support from other research firms and institutions as required.

Under the MOU, the parties will negotiate and enter into binding agreements (“Definitive Agreements”) that govern the Project, including the creation of a new entity that will hold an exclusive license to the Technology as it relates to REE Metal making. The MOU contemplates a phased development of the Project to scale-up to the production of 1,000 metric tonnes of one or more REE Metals per year. Energy Fuels will have the right to earn up to a 100% interest in the entity and Technology, as it relates to REE Metal making, by making the following capital investments:

  1. US$250,000 within five (5) business days after execution of the MOU;
  2. US$250,000 within five (5) business days after execution and delivery of the Definitive Agreements;
  3. US$1 million within five (5) business days after execution and delivery of the Definitive Agreements to be applied to the Project’s 2022 budget and work plan; and
  4. Energy Fuels will fund all future approved annual budgets as may be required for commercialization of the Project, up to a maximum additional expenditure of US$8.5 million over three (3) years, totaling US$10 million for the Project.

Upon the successful completion of the Project and the $10 million investment, Energy Fuels will control the exclusive rights to the entity and the Technology as it relates to REE Metal making. Energy Fuels will also have the right to cease funding at various decision points during the Project, at which point Energy Fuels will hold a percentage of the new entity and Technology, proportional to its amount contributed. If Energy Fuels ceases funding prior to earning 100% of the Technology, NSP will have the right in certain circumstances to acquire Energy Fuels’ interest in the entity and Technology by reimbursing Energy Fuels for its expenditures on the Project.

Mark S. Chalmers, President and CEO of Energy Fuels stated: “Metal-making is a critical step in the rare earth supply chain. Energy Fuels has already restored monazite ‘crack-and-leach’ capabilities to the U.S. at our White Mesa Mill in Utah, where today we are producing a high-purity mixed rare earth carbonate, which is ready for separation. No other company in the U.S. is currently producing a high-purity REE product ready for separation at commercial levels. We are also quickly moving toward adding solvent extraction separation equipment at the Mill and associated permitting that will allow us to produce commercial separated rare earth oxide powders in the coming years. In fact, we are already well advanced with piloting these capabilities on a continuous 24/7 basis at the Mill today.

“The next step in rare earth processing and refining is turning those separated rare earth oxide powders into usable rare earth metals and alloys, particularly NdPr metal needed for NdFeB magnets used in EVs, wind generation and other technologies. We are interested in Nanoscale Powders’ technology because we believe it has the potential to produce REE metals at lower cost, using less energy, and producing significantly less greenhouse gas emissions than conventional REE metal making methods. If successful, Nanoscale’s metal-making technology could be orders of magnitude safer and less expensive than the current established technology. This is the type of technology we as Americans need to develop to produce advanced rare earth materials in a cost-competitive manner, while achieving the highest standards of protection of public health, safety, and the environment. Nanoscale Powders has proven their technology on a small scale, and we look forward to working with them to advance the technology to pilot scale, and then to commercial scale in the coming years. Our relationship with Nanoscale Powders demonstrates Energy Fuels’ commitment to fully integrating a domestic REE processing supply chain in the most optimal and environmentally prudent manner possible.”

Implementation of this initiative is subject to the execution of Definitive Agreements.

ABOUT ENERGY FUELS

Energy Fuels is a leading U.S.-based uranium mining company, supplying U3O8 to major nuclear utilities. Energy Fuels also produces vanadium from certain of its projects, as market conditions warrant, and is ramping up to commercial-scale production of REE carbonate. Its corporate offices are in Lakewood, Colorado, near Denver, and all of its assets and employees are in the United States. Energy Fuels holds three of America’s key uranium production centers: the White Mesa Mill in Utah, the Nichols Ranch in-situ recovery (“ISR“) Project in Wyoming, and the Alta Mesa ISR Project in Texas. The White Mesa Mill is the only conventional uranium mill operating in the U.S. today, has a licensed capacity of over 8 million pounds of U3O8 per year, has the ability to produce vanadium when market conditions warrant, as well as REE carbonate from various uranium-bearing ores. The Nichols Ranch ISR Project is on standby and has a licensed capacity of 2 million pounds of U3O8 per year. The Alta Mesa ISR Project is also on standby and has a licensed capacity of 1.5 million pounds of U3O8 per year. In addition to the above production facilities, Energy Fuels also has one of the largest NI 43-101 compliant uranium resource portfolios in the U.S. and several uranium and uranium/vanadium mining projects on standby and in various stages of permitting and development. The primary trading market for Energy Fuels’ common shares is the NYSE American under the trading symbol “UUUU,” and the Company’s common shares are also listed on the Toronto Stock Exchange under the trading symbol “EFR.” Energy Fuels’ website is www.energyfuels.com.

ABOUT NANOSCALE

Nanoscale Powders LLC (www.nanoscalepowders.com) is a Boston-based, privately held company, operating patented processes capable of producing a wide range of engineered metal, alloy and ceramic powders and powder-derived products, including solids as well as additive-manufacturing powders. For further information, please contact Andrew.matheson@nanoscalepowders.com.

CAUTIONARY STATEMENTS REGARDING FORWARD LOOKING STATEMENTS

This news release contains “forward-looking information” within the meaning of applicable securities laws in the United States and Canada. Forward-looking information may relate to future events or future performance of Energy Fuels. All statements in this release, other than statements of historical facts, with respect to Energy Fuels’ objectives and goals, as well as statements with respect to its beliefs, plans, objectives, expectations, anticipations, estimates, and intentions, are forward-looking information. Specific forward-looking statements in this discussion include, but are not limited to, the following: any expectation that the Project will be successful; any expectation that the Project has the potential to revolutionize the rare earth metal making industry by reducing costs of production, reducing energy consumption and significantly reducing greenhouse gas emissions; any expectation that Energy Fuels will be successful in integrating a domestic REE processing supply chain in the most optimal and environmentally prudent manner possible or at all; any expectation that Energy Fuels will move quickly toward producing separated REE Oxides at the Mill using proven SX technologies or at all; any expectation that the Technology is a superior technology for the production of REE Metals; any expectation that application of the Technology does not result in any associated air emissions and therefore presents a significant improvement over the current technology; any expectation that the Technology is significantly cheaper to operate than the conventional electrolytic methods or that operating cost savings are potentially several times less than conventional methods; any expectation that Energy Fuels’ initial investment in the Project will advance the Technology to allow for the continuous, pilot-scale, production of 10 kilograms per hour of NdPr metal that meets typical specifications for NdFeB magnets at TLR Level 7 or that the other objectives of the Project will be achieved; any expectation that the parties will successfully negotiate and enter into binding Definitive Agreements such that the Project will proceed past the MOU stage; any expectation that Energy Fuels will earn a 100% interest in the Technology as it relates to REE Metal making; and any expectation that the Technology will be advanced to commercial scale in the coming years. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates” or “believes”, or variations of, or the negatives of, such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved. This information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements include risks associated with: technical difficulties; processing difficulties and upsets; the risk of elevated levels of oxygen in the final product; the risk of being able to successfully remove and consolidate final REE Metal products; licensing, permitting and regulatory delays; litigation risks; competition from others; and market factors, including future demand for and prices realized from the sale of REEs and REE Metals. Forward-looking statements contained herein are made as of the date of this news release, and Energy Fuels disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management’s estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. Energy Fuels assumes no obligation to update the information in this communication, except as otherwise required by law.

SOURCE Energy Fuels Inc.

For further information: ENERGY FUELS, Curtis Moore – VP of Marketing & Corporate Development, (303) 974-2154; cmoore@energyfuels.com

Helius Medical Technologies, Inc. Announces Issuance of U.S. Patent for Wireless PoNS®

Posted on by Admin



Helius Medical Technologies, Inc. Announces Issuance of U.S. Patent for Wireless PoNS®

Research, News, and Market Data on Helius Medical Technologies

 

Patent Readies Company for Next Generation of PoNS Therapy

NEWTOWN, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (Helius or the Company), a neurotech company focused on neurological wellness, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,197,994, which is directed to systems for providing non-invasive neurorehabilitation of a patient. The patent is similar in scope to prior Helius patents for the Portable Neuromodulation Stimulator (PoNS) device but expressly recites that the communications between the mouthpiece and controller are done wirelessly.

“We are pleased to announce our new patent, which will allow for a wireless connection between the mouthpiece and controller of our PoNS device,” said Dane Andreeff, President and Chief Executive Officer of Helius. “PoNS is the first and only patented therapy combining trigeminal nerve neurostimulation via the tongue with physical therapy to reduce symptoms of neurological disease or trauma, and this patent is an important building block for future generations of PoNS therapy.”

Helius now owns 34 U.S. and 46 foreign patents expiring between 2026 and 2036, and exclusively licenses nine U.S. medical method patents expiring between 2029 and 2031.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP).

PoNS is also authorized for sale in Canada for two indications: (i) PoNS is authorized as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) PoNS is authorized for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, visit www.heliusmedical.com.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “future,” “goal,” “aim” and similar expressions.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

The Gaming Market is Expanding with GameFi

Posted on by Admin

GameFi? What is Play to Earn

 

GameFi, a hot new trend emerging from the crypto industry, combines decentralized finance (DeFi) and non-fungible tokens (NFTs) with blockchain-based online games.

Unlike many traditional online games operating on a “pay-to-win” model, allowing players to purchase upgrades to gain an advantage over other players, GameFi introduces a “play-to-earn” model. This concept involves giving players financial incentives to play and progress through games. In some cases, allowing gamers to earn a full-time income by doing so.

Alien Worlds and similar GameFi projects, along with other play-to-earn games, are disrupting the traditional gaming industry as we know it. These play-to-earn crypto games are fundamentally blockchain-based monetization of the gaming experience. What distinguishes them from traditional games is the players play to earn rewards rather than to win. 

Predictably, the ability to financially reward players for their time and effort is behind the rapid growth in acceptance of these play-to-earn games, usually referred to as GameFi. Who wouldn’t like to earn cryptocurrency while having fun?

What Is GameFi?

A perfect combination between Gaming and Finance. GameFi, a very popular term in the cryptoverse, is a hybrid of “Gaming” and “Finance.” It describes the gamification of the working system creating profit from playing play-to-earn crypto games. 

GameFi projects run on a blockchain’s distributed ledger. All objects in these GameFi games are expressed as NFTs – digital tokens used to prove ownership of limited intangible items. This enables players to have certifiable ownership of virtual items in the game. In contrast to traditional gaming, where users play to win, GameFi projects adopt a play-to-earn model. Consider items such as plots of land, avatars, costumes, weapons, and gold bars. When players find and accumulate items during gameplay, they have the option to trade these in digital marketplaces for different NFTs or sell them in exchange for cryptocurrency.

Depending on which game is played, users can increase their earning potential by dedicating time leveling-up and improving their characters, creating monetized structures on their land which other gamers pay to use or by competing against others in tournaments. To keep track of player ownership, all NFTs and cryptocurrency transaction data is stored on a public blockchain.

Some GameFi projects also include DeFi elements, stalking where players are able to lock away certain tokens to earn annual interest and other rewards. They’re also able to save to purchase other in-game items or unlock new game content.

The term “GameFi” was first used to describe this new trend by Yearn.Finance founder Andre Cronje in a September 2020 tweet. Since then, the term has been widely used to refer to video games embedded with blockchain-powered decentralized financial elements. These projects take advantage of the popularity of video games, combined with unique features of cryptocurrencies, to make GameFi an exciting and growing space.

How
Do GameFi Projects Work?

Different GameFi projects typically have a few commonalities. In-game items such as avatars, land, costumes, weapons, gold, tokens, and pets are represented as NFTs—non-fungible digital tokens that prove ownership of these digital objects. Game players acquire these items through gameplay and can trade them on NFT marketplaces for profit or exchange them for cryptocurrencies — which can in turn be exchanged for fiat money.

What You
Need to Play

To take part in any these play-to-earn games, users will need to do the following:

  • Create
    a cryptocurrency wallet:     To store their virtual currency, NFTs and make in-game transactions. Which wallet you need will depend on which blockchain the game was built upon. For example, MetaMask – an Ethereum-based crypto wallet service – will work with any GameFi game built on Ethereum.
  • Purchase
    starter items:     All GameFi games are free to download. However, many require players to first purchase characters, native crypto tokens, decks of cards or upgrades to begin.
  • Pre-funded
    crypto wallet:     You will need to pre-fund your crypto wallet with a particular cryptocurrency to purchase starter items and proceed. Cryptoblades, for example, requires users to download MetaMask, purchase Binance coin (BNB) and exchange it for the game’s native cryptocurrency, SKILL.


How
Did GameFi Come Into Existence?

The emergence of GameFi comes from a combination of factors that dates back to 2017 and the emergence of the NFT phenomenon CryptoKitties. The digital collectibles economy proved a viral success, with CryptoKitties amassing over 14,914 users a day at its peak. CryptoPunks, a collection of 10,000 pixelated NFT characters also built on Ethereum, enjoyed similar success, surpassing $1 billion in sales and still growing.

Unfortunately, the success of these NFTs showed both the good and bad sides of the state of blockchain technology at the time. Games like CryptoKitties caused heavy congestion on the Ethereum network, leading to extreme spikes in transaction fees and much slower than normal transaction confirmation times. These technical issues highlighted a clear gap in the market for more efficient and scalable platforms that could handle the rising demand from online gamers and virtual asset collectors.

Since then, several new “Ethereum killer” blockchains have emerged, promising faster transaction speeds, greater scalability, and cheaper fees. These include the likes of Solana, Polkadot, and Cardano.

The increase of decentralized finance (DeFi) platforms over 2020 was the next significant component enabling GameFi’s growth, introducing a range of blockchain-native financial platforms that run entirely using smart contracts. This provided the infrastructure for decentralized exchanges where in-game cryptocurrencies could be launched from and traded, as well as additional features like lending and staking.

In September 2020, Yearn.finance founder and DeFi developer Andre Conje tweeted about the gamification of monetary policies in a decentralized environment. He recognized the many benefits DeFi and NFTs could bring to the online gaming industry, and GameFi applications quickly started to form. Axie Infinity was one of the first play-to-earn games to take off in a big way, surpassing $1 billion in revenue on Aug. 9, 2021.

GameFi
Expands its Reach

Early GameFi titles used the Bitcoin blockchain, but the cost of transactions and slow speed lead to the adoption of the smart contract-enabled blockchain network, Ethereum.Crypto.  Game developers, despite its performance issue, due to limited block space frequently use Ethereum.

Naturally, a game that requires exorbitant fees for in-game transactions will have difficulty gaining a significant user base. Faced with this problem, some crypto game developers moved from Ethereum’s base layer to faster networks, such as Polkadot, Solana, Polygon, Wax and BSC.  

GameFi projects have multiple levels to progress through. Players can increase earnings by dedicating time to improving their characters, monetizing their land assets through developing structures other players will pay to visit, or battling other players in tournaments. 

All data is stored on a decentralized public blockchain, keeping track of all players’ ownership. This way players, not the game developers, own all the assets, providing them the ability to monetize those assets. Since players maintain ownership of their assets even if a server is turned off or the gaming company suffers technical downtime.  Making crypto gaming an actual revenue-producing action for players.   

 

Additional
GameFi Advantages  

DeFi concepts like staking, liquidity mining and yield farming are gaining a traction in GameFi projects. These are additional ways players can earn in-game passive income. 
Staking their in-game assets, is a way players can earn annual interest and other rewards, which can be used to unlock new levels or to buy additional in-game items. Also, players can secure loans by collateralizing their game assets. 

Unlike traditional game development, which is centralized, GameFi projects may involve users in decision-making. Some games let players decide future game updates by giving stakeholders voting power, of the GameFi DAO (Decentralized Autonomous Organization).

A DAO allows token holders to vote on and suggest project updates, making GameFi truly participatory. These proposals usually have a financial impact, such as members of the DAO voting to increase the reward for a particular in-game action.

You must own a project’s governance token to be a member of the GameFi DAO. Typically, your voting power is directly proportional to the number of tokens you hold.

GameFi’s
New Concept “Play-to-Earn”

The play-to-earn model characteristic of GameFi projects is groundbreaking. Traditional online games make money through in-app purchases, affiliate marketing and advertising. As a player, you spend money buying in-game items to help you win or get an edge over other players. Of course, that spending goes directly to the game operators.

Also, if you’re like most players who grew up with online video game staples like Minecraft and PlayerUnknown’s Battlegrounds, you’ll be a custom to highly desirable in-game coins that have no value outside the game environment. Apart from the entertainment, you get nothing in return for your time and effort dedicated to playing these online games. With play to earn that has all changed.

This is where play-to-earn crypto games perform a 180 on the gaming industry: allowing gamers to add real-world value to their in-game purchases. In-game items and products are now NFT’s stored on a blockchain running on a crypto network. This blockchain technology allows in-game tokens and items to be traded for cryptocurrencies and, ultimately, actual cash. 

To heighten the gaming experience, online game players buy items like coins, weapons, extra lives, custom characters, outfits, avatars, accessories, etc., directly from the game. Traditional gameplay involves buying assets from stores owned by the game developers, enriching the developers and not the players. This can limit players’ online gaming experience, especially those who don’t have much cash to spend, resulting in a cost to play the games.  On the other hand, with crypto gaming, these purchases are made with cryptocurrencies and often involve trading valuable assets amongst players, providing the opportunity to go from a cost to the player to a revenue generation proposition for the gamer. 

This is a striking difference for the decentralized operations of GameFi projects, where players own globally distributed digital assets that aren’t limited to gaming purposes.

Minimal
or Zero Upfront Cost

Most GameFi games are free to download and play, which makes them more accessible than traditional games. While there are no upfront costs, some games may require you to purchase the in-game tokens, avatars, and other items to get started.

Easy-to-Learn
Games

GameFi projects incorporate simple gameplay mechanisms, an aspect that makes them easy to understand and navigate. This simple approach lowers the barrier to entry, driving considerable increase of potential players of all ages and experience levels can comfortably participate.

Future
Growth

Although GameFi’s origin can be traced to the early development of cryptocurrencies, it’s only recently gaining mainstream adoption. Demonstrated by the growth of the massive success of Axie Infinity. The popular GameFi project became the first to surpass $1 billion in token sales in August 2021 and has seen over a million daily active players. 

The constantly evolving technology behind crypto gaming has advanced to a level where new GameFi projects are attracting massive players & fan bases, as well as institutional funding. Industry experts believe crypto gaming to be the most likely gateway for widespread adoption and use of blockchain technology. As GameFi projects gain popularity with traditional gamers, understanding of crypto can only continue to flourish.

As you might expect, GameFi is increasingly taking up large piece of the growing $175 billion gaming market. Video gamers have long enjoyed and familiarized themselves with the concepts of in-game currencies, limited digital items and tokenization, all without gaining monetary value. Unquestionably, there will be a greater appeal to GameFi projects that comprise all these elements while directly rewarding players financially.

These are exciting times for GameFi. Leading industry players, such as game studios Ubisoft, Roblox Corporation and semiconductor makers, are part of the Blockchain Game

To further the growth of GameFI, an alliance is needed to provide infrastructure for game development, and forums for developers and players to network, collaborate and share knowledge, in addition to creating common standards.

GameFi is rapidly growing, and the collective market capitalization of leading blockchain games has topped $14 billion. But given the massive size of the gaming industry, the total addressable market offers even greater opportunities for growth.

With the runaway success of crypto games like Axie Infinity and CropBytes, the future of GameFi seems bright. With many more GameFi games in the works, newer innovations are expected. Some of the crypto gaming projects currently under development include:

  • Star Atlas
  • Ember Sword 
  • Guild of Guardians
  • The Sandbox
  • Who: Worlds Apart

 These newer games will provide even more opportunities for gamified profit and a feature-rich gaming experience. 

Gaming platforms like MOBOX are being designed to allow individuals to build their own NFTs and games with interoperability capabilities. The platform also features DeFi functionalities such as staking and liquidity pools, enabling gamers to generate income from their assets. This income can then be used to buy in-game upgrades or generate keys to unlock new NFTs.

Bottomline

GameFi has already gained significant traction, with the collective market capitalization of top games breaking $14 billion. But key opinion leaders in the crypto industry believe there’s a lot more ahead for this new sector, with Tron founder Justin Sun recently stating he believes this new sector will be key to increasing cryptocurrency adoption.

The GameFi concept is clearly an improvement over existing online game. The play-to-earn structure is ultimately the passport to broader crypto adoption as blockchain and NFT games suggest the future of the industry. It’s not surprising, this explosive trend shows no signs of slowing down. At this rate, GameFi and NFTs will become a rallying point for DeFi. With growing public interest and an influx of capital, prospects for this promising industry are limitless.

About the Author:

Peter Spoleti is CEO of  Vertex Markets. Vertex uses AI to make B2B introductions providing a business
networking site free from guesswork as to where the most valuable business
interactions are found.

Contact Vertex Markets here.

 

Suggested Reading:



What Is Yield Farming and Why All the Hype?

Blockchain Smart Contract Applications





Decentralized Apps Using Blockchain to Change the Internet

The Benefits of DeFi

 

Stay up to date. Follow us:

 

electroCore, Inc. Provides Update on nVNS to Treat Post Traumatic Stress Disorder

Posted on by Admin



electroCore, Inc. Provides Update on nVNS to Treat Post Traumatic Stress Disorder

News and Market Data on electroCore

 

ROCKAWAY, NJ, 
Dec. 14, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today provided an update on the ongoing clinical research to assess the potential of gammaCore (non-invasive vagal nerve stimulation; nVNS) to treat Post Traumatic Stress Disorder (“PTSD”).

PTSD is a debilitating disorder triggered by experiencing or witnessing a traumatic event that is increasingly common. Approximately 15 million adults in the US will have PTSD during a given year and it is particularly concerning to the Military and Veteran’s Administration (VA).

In a study published on 
December 6th, 2021, in the Journal of Affective Disorders Reports, 20 patients suffering from PTSD were exposed to personalized traumatic scripts followed by an immediate stimulation by an active or sham non-invasive vagus nerve stimulator (“nVNS”). The results showed that three-months of treatment with nVNS led to a 31% reduction (p<0.013) in PTSD symptoms compared to sham on the PTSD Checklist (“PCL”), as well as a significant decrease in hyperarousal symptoms (p=0.008) and a decrease in overall and somatic (gastric) anxiety. At the conclusion of the study, patients who continued using nVNS for a further 3 month open-label period showed significant improvement in their overall symptoms reported by the Clinical Global Index (p=0.003). Furthermore, nVNS effectively blocked the increase in the levels of the inflammatory cytokine IL-6 that is overexpressed in patients with PTSD who are exposed to a traumatic script (p<0.05).

electroCore is currently collaborating with investigators on two Randomized, sham-controlled clinical trials to further confirm the efficacy of nVNS as a treatment for PTSD. (Table 1)

Table 1. Ongoing Studies of nVNS in PTSD and Related Disorders
Study Size Location
nVNS in posttraumatic stress 88 VA San Diego Healthcare System, 
San Diego, CA
Sympathetic overactivity in PTSD 100 Atlanta VA Medical Center, 
Decatur, GA
 

“PTSD is a devastating condition that affects family and individuals across 
the United States. Whether it affects our active-duty service men and women, our Veteran’s, or friends and family, there are very few treatments that can decrease the signs and symptoms of nVNS” said  Dan Goldberger, CEO of electroCore. “gammaCore, which is currently cleared by the FDA for most forms of primary headache, offers the potential to provide a safe, convenient and effective treatment for people with PTSD. We look forward to reporting on our clinical and regulatory progress in 2022.”

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

  • Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

Safety and efficacy of gammaCore have not been evaluated in the following patients:

  • Adolescent patients with congenital cardiac issues
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric patients (less than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential utilizing nVNS for symptoms associated with Post Traumatic Stress Disorder (PTSD), the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

Virtual Roadshow with Cocrystal Pharma (COCP) Interim Co-CEOs Sam Lee, President & James Martin, CFO

Posted on by Admin

Cocrystal Pharma Interim Co-CEOs Sam Lee, President and James Martin, CFO make a formal corporate presentation. Afterwards they are joined by Noble Capital Markets Senior Research Analyst Robert LeBoyer for a Q & A session.

Research, News, and Advanced Market Data on COCP


Information on upcoming live virtual roadshows


Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

A Quick Look at 8 Small Caps in the Growing Psychedelics Space

Posted on by Admin 


	Image Credit – Pixabay - TherapeuticShroom

Psychedelic Medicine – The Next Breakthrough in Mental Health Treatment?

 

A Quick Look at 8 Small Caps in the Growing Psychedelics Space

After decades of restrictive regulation and social stigma, psychedelics are gaining headwinds as a potential treatment for various mental health conditions.

The term “psychedelic drugs” holds different meanings to different people. In counterculture, the term may refer to “magic mushrooms” or other drugs, such as ecstasy.  Purposely used to trigger hallucinations or altered states of consciousness, psychedelic drugs became popular in the 1960s, which led to harsh restrictions not only on possession and use for recreational purposes, but also on medical research.

Legal Hurdles

Research on the use of psychedelics was returning promising results in the early 20th century.  The Controlled Substances Act of 1970, following the increase in recreational use in the 60s, put up a barrier to researching the potential benefits, even for medical usage. A roadblock that the industry is only now starting to find a way past.

In recent years, the Food and Drug Administration (FDA) has granted psychedelic compounds Breakthrough Therapy status, which has opened the door to new research studies and the potential development of new medications.  Recently, research and approval of new drugs has progressed past phase 2 trials for the use of psilocybin – the naturally occurring psychedelic prodrug compound produced by numerous fungi species – as treatment for depressive disorder. In another example, a drug proposed for the treatment of certain PTSD diagnoses is heading towards a second phase 3 trial, with full FDA approval possible as early as 2022.

Beyond FDA Approval

Potential FDA approval is just the first step. The United States Drug Enforcement Administration (DEA), and, by proxy, the Controlled Substances Act, are next in line.  Psychedelic compounds generally fall into Schedule 1 classification: the most restrictive.  By law, Schedule 1 drugs cannot be prescribed to treat any condition under any circumstances. While this may seem insurmountable, full FDA approval of a drug would likely force the DEA to reevaluate their position.

Beyond Federal regulation, there’s also individual state laws. Consider the current state of cannabis and marijuana legalization and decriminalization from state to state.  While some have fully approved the use of marijuana both recreationally and medically, others have varying levels of restriction on either use-case.  The same is likely to be true for the use of psychedelics for medicinal use.

Prescriptions

Proposed psychedelic treatments often run in-tandem with hours of mental health therapy sessions.  In fact, more than 90% of the cost associated with the entire regimen is attributed to therapy in some cases. While this exceeds the costs associated with the current treatment schedule for these conditions, proven increased efficacy of psychedelics, especially in treatment of previously untreatable conditions, would reduce third-party payer expenditures.

Considering the toll the opioid epidemic has taken, there is also likely to be increased scrutiny on the prescription of psychedelic therapies, even if the DEA adjusts their classification. 

Even with numerous hurdles, several doctors, organizations, and companies see the potential of psychedelics as treatment for various mental health issues, including depression, PTSD, anxiety, eating disorders, and substance use disorders.  In most cases, early research has shown efficacy surpassing any currently available treatment schedule.  In some, psychedelics may represent a portion of the first truly effective treatment schedule. 

The psychedelic medicine market is expected to grow exponentially as FDA approvals start to come in, with some speculating the market will reach a value of over $3 billion by 2026.

 

Companies Involved in Psychedelic Medicine

PsyBio
Therapeutics – PSYBF

PsyBio is a biotechnology company focused on discovery and development of psycho-targeted therapeutics to potentially improve mental and neurological health. They are currently researching and developing treatments based on psychoactive tryptamines originally discovered in hallucinogenic mushrooms, as well as other tryptamines, phenethylamines, and combinations thereof.

PsyBio has built a portfolio of more than 80 molecules. Their development focus is “cheaper, faster, greener psychedelic inspired compound discovery and production.”

Recently, the company announced the successful completion of their initial pre-Investigational New Drug application meeting with the FDA as part of the regulatory submission process

View the most recent research report on PSYBF at the link
above for applicable disclosures

Filament
Health – FLHLF

Filament Health is an exclusively natural psychedelic drug discovery and extraction technology company.  Their focus is in bringing safe, approved, natural psychedelic medicines to market as soon as possible. Filment’s wholly owned subsidiary Psilo Scientific propagates psychedelic plants, conducts research, performs extraction, runs in-house trials, and distributes IP and drug candidates.

Recently, the company announced FDA authorization to initiate its first clinical trial using psychedelic substances, a first for the direct administration of psilocin (rather than its prodrug psilocybin). The Translational Psychedelic Research Program at the University of California San Francisco will lead the phase 1 trial.

The company also anticipates FDA authorization of a phase 2 trial for PEX010, to test safety and efficacy in the treatment of Major Depressive Disorder by year end.

View the most recent research report on PSYBF at the link
above for applicable disclosures

Levitee
Labs – LVTTF

Levitee Labs is focused on mental health and addiction treatments through the integration of psychedelic medicines and therapies. Leveraging an M&A regimen, they aim to create a centralized network of complementary integrative assets.  The company’s current portfolio includes Levitee Clinics – a group of addiction and pain treatment clinics, Levitee Pharmacies – specializing in filling prescriptions for substance use, mental health, and chronic pain patients, BlockMD – an electronic prescription platform in the addiction treatment space, and Earth Circle Organics – a wholesaler of supplements and superfood products.

Revive
Therapeutics – RVVTF

Revive Therapeutics is a life sciences company focused on research and development of therapeutics for rare disorders and infections diseases.  Revive boasts a robust cannabinoid pharmaceutical portfolio focused on rare inflammatory diseases. Recently, they acquired Psilocin Pharma. This acquisition positions them to advance psilocybin-based therapeutics.  They are also exploring the use of Bucillamine for the potential treatment of infectious diseases, including COVID-19.

On the recent acquisition of Psilocin Pharma, Revive CEO Michael Frank stated: “Psilocin Pharma has the platform, relationships, and know-how to develop psylocibin-based products that are key to this emerging psychedelics industry. We feel this acquisition will complement Revive and be a strong addition to our current clinical initiatives in liver disease and inflammation.”

In November, the company announced it had entered into a research collaboration agreement with PharmaTher Holdings to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle path technology for neuropsychiatric disorders.

Cybin
– CYBN

Cybin is an ethical biopharmaceutical company focused on progressing psychedelics to therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

The company’s pipeline currently includes 6 programs, including EMBARK, utilizing psilocybin for mental distress in frontline healthcare workers, currently in phase 1 trial. Other preclinical programs include studying psychedelic effects on the brain and psilocybin as treatment for major depressive disorder and alcohol use disorder.

At the end of November, Cybin announced that the FDA had authorized an investigator-initiated randomized, placebo-controlled phase 2 clinical trial evaluating psychotherapy with psilocybin for frontline worders experiencing COVID-related distress.

Field
Trip Health – FTRP

Field Trip is focused on an integrated, evidence-based approach to healing utilizing psychedelic-enhanced therapies. Their portfolio includes Field Trip Health – technology empowered clinics providing psychedelic therapies, Field Trip Digital – an app & resources platform, and Field Trip Discovery – their drug development division focused on psychedelic molecules.

Field Trip’s treatment regimen includes analysis, therapy session, psychedelic exploration, and integration. Their treatment program is designed to help individuals suffering from treatment resistant mental health conditions such as depression, anxiety, and trauma.

Compass
Pathways – CMPS

Compass is a mental health care company focused on acceleration patient access to psilocybin therapy.  COMP360, a proprietary formulation of synthetic psilocybin, is focused on those suffering from treatment resistant depression. They received FDA Breakthrough Therapy designation for the program in 2018 and completed a phase 2b study in 233 patients in late 2021. According to the company, this was the largest randomized, controlled, double-blind psilocybin therapy clinical trial ever conducted. They expect to begin phase 3 in 2022. Compass is also running a phase 2 clinical trial of their psilocybin therapy for treatment of PTSD.

ATAI
Life Sciences – ATAI

ATAI is a biopharmaceutical company focused on highly effective mental health treatments that address the unmet needs to patients. The company utilizes proprietary technology and big-data approaches to accelerate drug discovery.

The company has two programs currently in phase 2: PCN-101 for patients experiencing treatment resistant depression, and RL-007 for the treatment of Cognitive Impairment Associated with Schizophrenia. Recently, Atai announced a successful outcome of the phase 2a biomarker trial of RL-007. They also have two programs currently in phase 1: DMZ-1002 for the treatment of opioid use disorder, and GRX-917 for the treatment of anxiety disorder.

In Conclusion

Mental health awareness has increased significantly in recent years, while the development of medications has not kept up with the demand for treatment.  The implementation of psychedelics, in conjunction with a therapy schedule, may create a path to wellness not previously available for many patients.  Early efficacy trials have certainly shown the potential that lies ahead. 

Investing in an early-stage medical platform company, like any other investment, carries its own risks. Before making an investment decision in any company, make sure you understand the risks associated, and consult your investment advisor.

Chris Patches
Channelchek Contributor

Suggested Reading:



Psychedelic Laws and Investments May Follow Cannabis’ Success

Acceptance of Psychedelics for Wellness and Recreation

Sources:

https://www.amjmed.com/article/S0002-9343(21)00521-0/fulltext

https://medicine.umich.edu/dept/psychiatry/news/archive/202108/therapeutic-potential-psychedelics-psychiatric-disorders

https://www.health.harvard.edu/blog/back-to-the-future-psychedelic-drugs-in-psychiatry-202106222508

https://www.financialnewsmedia.com/north-american-psychedelic-drugs-market-expected-to-reach-a-value-of-3-184-billion-in-2026/

https://www.psybiolife.com/press

https://filament.health/our-technology/

https://finance.yahoo.com/news/filament-health-announces-fda-authorization-114500736.html

https://leviteelabs.com/category/press-releases/

https://revivethera.com/2020/02/revive-enters-into-psychedelics-market-with-letter-of-intent-to-acquire-psilocin-pharma-corp/

https://revivethera.com/2021/11/revive-therapeutics-enters-into-research-collaboration-agreement-with-pharmather-for-development-of-psilocybin-microneedle-patch/

https://cybin.com/development-pipeline/

https://ir.cybin.com/investors/news/news-details/2021/Cybin-Announces-FDA-Investigational-New-Drug-and-Institutional-Review-Board-Approvals-for-a-Co-Funded-Phase-2-Clinical-Trial-to-Treat-Frontline-Clinicians-Experiencing-COVID-Related-Distress/default.aspx

https://www.fieldtriphealth.com/our-treatments#treatment

https://compasspathways.com/

https://www.atai.life/programs/

 

Stay up to date. Follow us: